Back to resultsAcute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)
Primary Purpose
Ischemic Heart Disease, Cardiovascular Diseases, Arteriosclerosis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- Patient is older than or equal to 18 years
- The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity stent
- The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
- Intention to implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI)
- Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations
Exclusion Criteria:
- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- A woman who is pregnant, planning to be pregnant or lactating
- Currently participating in another trial
- Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period
- Previous enrollment in the China Resolute Integrity Study
Sites / Locations
- Wuhan Asia Heart Hospital
- Nanjing First Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Arm Description
This is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study.
Outcomes
Primary Outcome Measures
Device Specific Procedural Success
Defined as device success (the attainment of less than 50% residual stenosis of the target lesion using only the study device) and no in-hospital MACE (composite of death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization).
Secondary Outcome Measures
Delivery Success
Defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.
Device Success
defined as the attainment of less than 50% residual stenosis of the target lesion using only the Resolute Integrity stent.
Lesion Success
Defined as the attainment of less than 50% residual stenosis by any percutaneous method.
Procedure Success
Defined as the attainment of less than 50% residual stenosis by any percutaneous method and no in-hospital MACE.
In-hospital Major Adverse Cardiac Events (MACE)
Defined as the composite of as in-hospital death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (TLR; clinically driven/clinically indicated) by percutaneous or surgical method.
In-hospital Target Lesion Failure (TLF)
Defined as the composite of cardiac death, myocardial infarction (not clearly attributable to a non-target vessel) or target lesion revascularization (TLR; clinically indicated).
Procedure time (min)
Resource Utilization
Contrast volume used (ml)
Resource Utilization
Usage of guiding catheters
Resource Utilization
Usage of guide wires
Resource Utilization
Usage of angioplasty balloons
Resource Utilization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02452736
Brief Title
Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)
Official Title
CHINA RESOLUTE INTEGRITY STUDY Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use --A Prospective, Multi-center, Single Arm, Non-randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to conduct a prospective, multi-center, single arm, non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
Detailed Description
This is a Pre-market, Prospective, Multi-center, Single arm, Non-randomized Study.
The objective of this study is to:
To assess the deliverability of the Resolute Integrity Stent for suitable patients according to Indication for Use with a reference vessel diameter (RVD) of 2.25 mm to 4.0 mm in 200 evaluable patients
To assess the in-hospital Major Adverse Cardiac Event (MACE) rate
To collect data on resource utilization in the catheterization lab. At least 200 evaluable patients from about 15 study centers in China who meet the eligibility criteria and sign the informed consent form will participate in this study.
The expected time of participation in the study for each subject is from informed consent sign-off up to hospital discharge.
An angiographic core laboratory and a Clinical Events Committee (CEC) will be utilized. Adjudication of pre-specified clinical endpoint events will be done by an independent Clinical Events Committee. An angiographic core laboratory will review all baseline, procedural, and clinical event angiograms for all patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Arm Type
Experimental
Arm Description
This is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study.
Intervention Type
Device
Intervention Name(s)
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Primary Outcome Measure Information:
Title
Device Specific Procedural Success
Description
Defined as device success (the attainment of less than 50% residual stenosis of the target lesion using only the study device) and no in-hospital MACE (composite of death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization).
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Secondary Outcome Measure Information:
Title
Delivery Success
Description
Defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
Title
Device Success
Description
defined as the attainment of less than 50% residual stenosis of the target lesion using only the Resolute Integrity stent.
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
Title
Lesion Success
Description
Defined as the attainment of less than 50% residual stenosis by any percutaneous method.
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
Title
Procedure Success
Description
Defined as the attainment of less than 50% residual stenosis by any percutaneous method and no in-hospital MACE.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Title
In-hospital Major Adverse Cardiac Events (MACE)
Description
Defined as the composite of as in-hospital death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (TLR; clinically driven/clinically indicated) by percutaneous or surgical method.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Title
In-hospital Target Lesion Failure (TLF)
Description
Defined as the composite of cardiac death, myocardial infarction (not clearly attributable to a non-target vessel) or target lesion revascularization (TLR; clinically indicated).
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Title
Procedure time (min)
Description
Resource Utilization
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
Title
Contrast volume used (ml)
Description
Resource Utilization
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
Title
Usage of guiding catheters
Description
Resource Utilization
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
Title
Usage of guide wires
Description
Resource Utilization
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
Title
Usage of angioplasty balloons
Description
Resource Utilization
Time Frame
Participants will be followed at the end of index procedure, an expected average of 3 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is older than or equal to 18 years
The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity stent
The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
Intention to implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI)
Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations
Exclusion Criteria:
Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
A woman who is pregnant, planning to be pregnant or lactating
Currently participating in another trial
Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period
Previous enrollment in the China Resolute Integrity Study
Facility Information:
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
12. IPD Sharing Statement
Learn more about this trial
Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)
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