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SPIRIT PRIME Clinical Trial (SPIRIT PRIME)

Primary Purpose

Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Core size Xience Prime
Xience Prime Long Lesion (LL)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring drug eluting stents, stents, Angioplasty, myocardial ischemia, coronary artery stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Long lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
  4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. Subject must agree to undergo all protocol-required follow-up procedures.
  6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

  1. One or two de novo target lesions each in a different epicardial vessel.
  2. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

    o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.

  3. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
  4. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:

    • ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS
    • ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS
  5. Target lesion(s) must be located in a native coronary artery with length by visual estimation of:

    • ≤ 22 mm for treatment by the core size XIENCE PRIME EECS
    • > 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS

Exclusion Criteria:

  1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
  2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
  4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
  5. Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
  6. Subject has received any organ transplant or is on a waiting list for any organ transplant.
  7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
  8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
  9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
  10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
  11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
  12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
  14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
  15. Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
  16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
  18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
  22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

  1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
  2. Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.
  3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
  4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
  5. Restenotic target lesion.
  6. Aorto-ostial target lesion (within 3 mm of the aorta junction).
  7. Target lesion is in a left main location.
  8. Target lesion located within 2 mm of the origin of the LAD or LCX.
  9. Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion.
  10. Heavy calcification proximal to or within the target lesion.
  11. Target vessel contains thrombus as indicated in the angiographic images.
  12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).
  13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
  14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.
  15. Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.

Sites / Locations

  • Thomas Hospital
  • Scottsdale Healthcare
  • Mercy General Hospital
  • Washington Hospital Center
  • Morton Plant Hospital
  • St. Vincents Medical Center
  • Orlando Regional Medical Center
  • Sacred Heart Hospital of Pensicola
  • St. John's Hospital
  • St. Vincent Heart Center of Indiana
  • Iowa Heart Center P.C.
  • University of Kansas Hospital
  • Willis Knighton Health System, Pierremont
  • Union Memorial Hospital
  • Johns Hopkins Hospital
  • Peninsula Regional Medical Center
  • Washington Adventist Hospital
  • Cape Cod Hospital
  • Bay Regional Medical Center
  • Borgess Medical Center
  • Northern Michigan Hospital
  • Beaumont Hospital
  • Abbott Northwestern Hospital
  • St. Luke's Hospital
  • Barnes Jewish Hospital
  • St. Patrick Hospital
  • Cooper Health System
  • The Valley Hospital
  • Gotham Cardiology
  • Mount Sinai Medical Center
  • Presbyterian Hospital - Charlotte
  • Forsyth Medical Center
  • Wake Forest University Baptist Medical Center
  • The Christ Hospital
  • University Hospitals of Cleveland
  • Riverside Methodist Hospital
  • EMH Regional Medical Center
  • St. Vincent Mercy Medical Center
  • Hillcrest Medical Center
  • Providence St. Vincent Medical Center
  • Geisinger Medical Center
  • Pinnacle Health @ Harrisburg Hospital
  • Allegheny General Hospital
  • AnMed Health
  • Sanford USD Medical Center
  • Wellmont Holston Valley Medical Center
  • Northwest Texas Healthcare System
  • Heart Hospital of Austin
  • St. Luke's Episcopal Hospital
  • The Methodist Hospital
  • Fletcher Allen Health Care
  • Sentara Norfolk General Hospital
  • Overlake Hospital Medical Center
  • St. Joseph Hospital
  • Heart Clinics Northwest/ Sacred Heart Medical Center
  • Aurora St. Luke's Medical Center
  • Wesley Hospital
  • The Prince Charles Hospital
  • Monash Heart
  • St. Vincent's Hospital
  • Epworth Hospital
  • Royal Perth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Core size registry (CSR)

Long lesion registry (LLR)

Arm Description

Core size indicates the range of diameters of the stents used.

Use of long lesion stents.

Outcomes

Primary Outcome Measures

Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Secondary Outcome Measures

Procedure Time
Procedure time is defined as time between insertion and withdrawal of guide catheter.
Device Success (Lesion Basis)
Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).
Procedural Success (Subject Basis)
Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.
All Death (Cardiac, Vascular, Non-cardiovascular)
All Death (Cardiac, Vascular, Non-cardiovascular)
All Death (Cardiac, Vascular, Non-cardiovascular)
All Death (Cardiac, Vascular, Non-cardiovascular)
All Death (Cardiac, Vascular, Non-cardiovascular)
All Death (Cardiac, Vascular, Non-cardiovascular)
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Clinically Indicated-Target Lesion Revascularization
Clinically Indicated-Target Lesion Revascularization
Clinically Indicated-Target Lesion Revascularization
Clinically Indicated-Target Lesion Revascularization
Clinically Indicated-Target Lesion Revascularization
Clinically Indicated-Target Lesion Revascularization
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
All TLR (CI and Non-CI)
All TLR (CI and Non-CI)
All TLR (CI and Non-CI)
All TLR (CI and Non-CI)
All TLR (CI and Non-CI)
All TLR (CI and Non-CI)
All TVR (CI and Non-CI)
All TVR (CI and Non-CI)
All TVR (CI and Non-CI)
All TVR (CI and Non-CI)
All TVR (CI and Non-CI)
All TVR (CI and Non-CI)
All Coronary Revascularization (TVR and Non-TVR)
All Coronary Revascularization (TVR and Non-TVR)
All Coronary Revascularization (TVR and Non-TVR)
All Coronary Revascularization (TVR and Non-TVR)
All Coronary Revascularization (TVR and Non-TVR)
All Coronary Revascularization (TVR and Non-TVR)
Cardiac Death/All MI
Cardiac Death/ All MI
Per Protocol
Cardiac Death/All MI
Per Protocol
Cardiac Death/All MI
Per Protocol
Cardiac Death/All MI
Per Protocol
Cardiac Death/All MI
Per Protocol
Cardiac Death/ All MI/CI-TLR
Cardiac Death/ All MI/CI-TLR
Per Protocol
Cardiac Death/ All MI/CI-TLR
Per Protocol
Cardiac Death/ All MI/CI-TLR
Per Protocol
Cardiac Death/ All MI/CI-TLR
Per Protocol
Cardiac Death/ All MI/CI-TLR
Per Protocol
All Death/All MI/All Coronary Revascularization
Per Protocol
All Death/All MI/All Coronary Revascularization
Per Protocol
All Death/All MI/All Coronary Revascularization
Per Protocol
All Death/All MI/All Coronary Revascularization
Per Protocol
All Death/All MI/All Coronary Revascularization
Per Protocol
All Death/All MI/All Coronary Revascularization
Per Protocol
Stent Thrombosis
Per protocol and per Academic Research Consortium (ARC, definite/probable)
Stent Thrombosis
Per protocol and per ARC
Stent Thrombosis
Per protocol and per ARC
Stent Thrombosis
Per protocol and per ARC
Stent Thrombosis
Per protocol
Stent Thrombosis
Per ARC, definite and probable
Stent Thrombosis
Per protocol
Stent Thrombosis
Per ARC, definite and probable
Stent Thrombosis
Per protocol and per ARC
Stent Thrombosis
Per protocol
Stent Thrombosis
Per ARC, definite and probable
Stent Thrombosis
Per protocol
Stent Thrombosis
Per ARC, definite and probable

Full Information

First Posted
June 5, 2009
Last Updated
May 12, 2015
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00916370
Brief Title
SPIRIT PRIME Clinical Trial
Acronym
SPIRIT PRIME
Official Title
SPIRIT PRIME Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
drug eluting stents, stents, Angioplasty, myocardial ischemia, coronary artery stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Long lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
525 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core size registry (CSR)
Arm Type
Experimental
Arm Description
Core size indicates the range of diameters of the stents used.
Arm Title
Long lesion registry (LLR)
Arm Type
Experimental
Arm Description
Use of long lesion stents.
Intervention Type
Device
Intervention Name(s)
Core size Xience Prime
Intervention Description
Core size includes a range of stent sizes.
Intervention Type
Device
Intervention Name(s)
Xience Prime Long Lesion (LL)
Intervention Description
Long lesion stent sizes include a range of sizes.
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)
Description
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time Frame
1 year
Title
Target Lesion Failure (TLF)
Description
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time Frame
2 years
Title
Target Lesion Failure (TLF)
Description
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Procedure Time
Description
Procedure time is defined as time between insertion and withdrawal of guide catheter.
Time Frame
From insertion to withdrawal of guide catheter
Title
Device Success (Lesion Basis)
Description
Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).
Time Frame
From the start of index procedure to end of index procedure
Title
Procedural Success (Subject Basis)
Description
Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.
Time Frame
From the start of index procedure to end of index procedure
Title
All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame
In-hospital is less than or equal to 7 days post index procedure
Title
All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame
30 days
Title
All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame
180 days
Title
All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame
1 year
Title
All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame
2 years
Title
All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame
3 years
Title
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description
Per Protocol
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.
Title
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description
Per Protocol
Time Frame
30 days
Title
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description
Per Protocol
Time Frame
180 days
Title
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description
Per Protocol
Time Frame
1 year
Title
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description
Per Protocol
Time Frame
2 years
Title
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description
Per Protocol
Time Frame
3 years
Title
Non-target Vessel MI (Q-wave, Non Q-wave)
Description
Per Protocol
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
Non-target Vessel MI (Q-wave, Non Q-wave)
Description
Per Protocol
Time Frame
30 days
Title
Non-target Vessel MI (Q-wave, Non Q-wave)
Description
Per Protocol
Time Frame
180 days
Title
Non-target Vessel MI (Q-wave, Non Q-wave)
Description
Per Protocol
Time Frame
1 year
Title
Non-target Vessel MI (Q-wave, Non Q-wave)
Description
Per Protocol
Time Frame
2 years
Title
Non-target Vessel MI (Q-wave, Non Q-wave)
Description
Per Protocol
Time Frame
3 years
Title
Clinically Indicated-Target Lesion Revascularization
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
Clinically Indicated-Target Lesion Revascularization
Time Frame
30 days
Title
Clinically Indicated-Target Lesion Revascularization
Time Frame
180 days
Title
Clinically Indicated-Target Lesion Revascularization
Time Frame
1 year
Title
Clinically Indicated-Target Lesion Revascularization
Time Frame
2 years
Title
Clinically Indicated-Target Lesion Revascularization
Time Frame
3 years
Title
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame
30 days
Title
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame
180 days
Title
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame
1 year
Title
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame
2 years
Title
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame
3 years
Title
All TLR (CI and Non-CI)
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
All TLR (CI and Non-CI)
Time Frame
30 days
Title
All TLR (CI and Non-CI)
Time Frame
180 days
Title
All TLR (CI and Non-CI)
Time Frame
1 year
Title
All TLR (CI and Non-CI)
Time Frame
2 years
Title
All TLR (CI and Non-CI)
Time Frame
3 years
Title
All TVR (CI and Non-CI)
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
All TVR (CI and Non-CI)
Time Frame
30 days
Title
All TVR (CI and Non-CI)
Time Frame
180 days
Title
All TVR (CI and Non-CI)
Time Frame
1 year
Title
All TVR (CI and Non-CI)
Time Frame
2 years
Title
All TVR (CI and Non-CI)
Time Frame
3 years
Title
All Coronary Revascularization (TVR and Non-TVR)
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
All Coronary Revascularization (TVR and Non-TVR)
Time Frame
30 days
Title
All Coronary Revascularization (TVR and Non-TVR)
Time Frame
180 days
Title
All Coronary Revascularization (TVR and Non-TVR)
Time Frame
1 year
Title
All Coronary Revascularization (TVR and Non-TVR)
Time Frame
2 years
Title
All Coronary Revascularization (TVR and Non-TVR)
Time Frame
3 years
Title
Cardiac Death/All MI
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
Cardiac Death/ All MI
Description
Per Protocol
Time Frame
30 days
Title
Cardiac Death/All MI
Description
Per Protocol
Time Frame
180 days
Title
Cardiac Death/All MI
Description
Per Protocol
Time Frame
1 year
Title
Cardiac Death/All MI
Description
Per Protocol
Time Frame
2 years
Title
Cardiac Death/All MI
Description
Per Protocol
Time Frame
3 years
Title
Cardiac Death/ All MI/CI-TLR
Time Frame
in-hospital
Title
Cardiac Death/ All MI/CI-TLR
Description
Per Protocol
Time Frame
30 days
Title
Cardiac Death/ All MI/CI-TLR
Description
Per Protocol
Time Frame
180 days
Title
Cardiac Death/ All MI/CI-TLR
Description
Per Protocol
Time Frame
1 year
Title
Cardiac Death/ All MI/CI-TLR
Description
Per Protocol
Time Frame
2 years
Title
Cardiac Death/ All MI/CI-TLR
Description
Per Protocol
Time Frame
3 years
Title
All Death/All MI/All Coronary Revascularization
Description
Per Protocol
Time Frame
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Title
All Death/All MI/All Coronary Revascularization
Description
Per Protocol
Time Frame
30 days
Title
All Death/All MI/All Coronary Revascularization
Description
Per Protocol
Time Frame
180 days
Title
All Death/All MI/All Coronary Revascularization
Description
Per Protocol
Time Frame
1 year
Title
All Death/All MI/All Coronary Revascularization
Description
Per Protocol
Time Frame
2 years
Title
All Death/All MI/All Coronary Revascularization
Description
Per Protocol
Time Frame
3 years
Title
Stent Thrombosis
Description
Per protocol and per Academic Research Consortium (ARC, definite/probable)
Time Frame
Acute (≤1 day)
Title
Stent Thrombosis
Description
Per protocol and per ARC
Time Frame
Subacute (>1 - 30 days)
Title
Stent Thrombosis
Description
Per protocol and per ARC
Time Frame
Acute/Subacute (0 - 30 days)
Title
Stent Thrombosis
Description
Per protocol and per ARC
Time Frame
Late (31 - 393 days)
Title
Stent Thrombosis
Description
Per protocol
Time Frame
Late (31 - 758 days)
Title
Stent Thrombosis
Description
Per ARC, definite and probable
Time Frame
Very Late (394 - 758 days)
Title
Stent Thrombosis
Description
Per protocol
Time Frame
Late (31 - 1123 days)
Title
Stent Thrombosis
Description
Per ARC, definite and probable
Time Frame
Very Late (394 - 1123 days)
Title
Stent Thrombosis
Description
Per protocol and per ARC
Time Frame
Overall (0-393 days)
Title
Stent Thrombosis
Description
Per protocol
Time Frame
Overall (0-758 days)
Title
Stent Thrombosis
Description
Per ARC, definite and probable
Time Frame
Overall (0-758 days)
Title
Stent Thrombosis
Description
Per protocol
Time Frame
Overall (0 - 1123 days)
Title
Stent Thrombosis
Description
Per ARC, definite and probable
Time Frame
Overall (0 - 1123 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be at least 18 years of age. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia). Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. Subject must agree to undergo all protocol-required follow-up procedures. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria One or two de novo target lesions each in a different epicardial vessel. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry. o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of: ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS Target lesion(s) must be located in a native coronary artery with length by visual estimation of: ≤ 22 mm for treatment by the core size XIENCE PRIME EECS > 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS Exclusion Criteria: Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary). Subject has received coronary brachytherapy in any epicardial vessel (target or non target). Subject has received any organ transplant or is on a waiting list for any organ transplant. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.). Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin). Subject will require Low Molecular Weight Heparin (LMWH) post-procedure. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis). Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis). Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). Subject is currently participating in another clinical study that has not yet completed its primary endpoint. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft. Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion. Restenotic target lesion. Aorto-ostial target lesion (within 3 mm of the aorta junction). Target lesion is in a left main location. Target lesion located within 2 mm of the origin of the LAD or LCX. Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion. Heavy calcification proximal to or within the target lesion. Target vessel contains thrombus as indicated in the angiographic images. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon). Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure. Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure. Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Costa, MD, PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
St. Vincents Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Hospital of Pensicola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504-8721
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Iowa Heart Center P.C.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Willis Knighton Health System, Pierremont
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Cape Cod Hospital
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Patrick Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Cooper Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Gotham Cardiology
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Mount Sinai Medical Center
City
NY
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Presbyterian Hospital - Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
EMH Regional Medical Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Pinnacle Health @ Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Northwest Texas Healthcare System
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Pearland
State/Province
Texas
ZIP/Postal Code
77581
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Overlake Hospital Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
St. Joseph Hospital
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Heart Clinics Northwest/ Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wesley Hospital
City
Auchenflower
State/Province
Queensland
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4061
Country
Australia
Facility Name
Monash Heart
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St. Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Epworth Hospital
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia

12. IPD Sharing Statement

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SPIRIT PRIME Clinical Trial

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