Back to resultsNEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant female patients 18 years of age Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia; Treatment of a single de novo target lesion in a major native coronary artery; Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate); Target lesion is 30mm in length (visual estimate); Target lesion stenosis is > 50% and < 100% (visual estimate); Exclusion Criteria: Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment; Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina; Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; Documented Left ventricular ejection fraction 25%; Totally occluded vessel (TIMI 0 level); Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Sites / Locations
- Texas Heart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion
Secondary Outcome Measures
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00231283
Brief Title
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
Official Title
A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Intervention Type
Device
Intervention Name(s)
CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
Intervention Description
CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
Description
Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion
Time Frame
From post-procedure up to hospital discharge
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later
Description
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Time Frame
From post-procedure up to 30 days
Title
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge
Description
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Time Frame
From post-procedure up to hospital discharge
Title
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later
Description
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Time Frame
From post-procedure up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant female patients 18 years of age
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
Treatment of a single de novo target lesion in a major native coronary artery;
Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
Target lesion is 30mm in length (visual estimate);
Target lesion stenosis is > 50% and < 100% (visual estimate);
Exclusion Criteria:
Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Documented Left ventricular ejection fraction 25%;
Totally occluded vessel (TIMI 0 level);
Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emerson Perin, MD
Organizational Affiliation
Texas Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
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