Back to resultsStudy of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
4.0 CYPHER Sirolimus-Eluting Coronary Stent
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 minimum 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; Target lesions treatable with 4mm stent (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 remains above normal at the time of treatment; Has unstable angina classified as Braunwald III B or C, or is having a peri infarction; Documented Left ventricular ejection fraction 25%; Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Sites / Locations
- Brigham & Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
Secondary Outcome Measures
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced
Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.
In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.
Target lesion revascularization (TLR) at 6 and 9 months post-procedure.
Target vessel revascularization (TVR) at 6 and 9 months post-procedure.
Target vessel failure (TVF) at 6 and 9 months post-procedure.
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers.
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232752
Brief Title
Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Official Title
A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss 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
Intervention Type
Device
Intervention Name(s)
4.0 CYPHER Sirolimus-Eluting Coronary Stent
Intervention Description
4.0 CYPHER Sirolimus-Eluting Coronary Stent
Primary Outcome Measure Information:
Title
The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced
Time Frame
30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure
Title
Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.
Time Frame
6 months post-procedure
Title
In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.
Time Frame
6 months post-procedure
Title
Target lesion revascularization (TLR) at 6 and 9 months post-procedure.
Time Frame
6 and 9 months post-procedure
Title
Target vessel revascularization (TVR) at 6 and 9 months post-procedure.
Time Frame
6 and 9 months post-procedure
Title
Target vessel failure (TVF) at 6 and 9 months post-procedure.
Time Frame
6 and 9 months post-procedure
Title
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers.
Time Frame
post-procedure and six months in a subset of approximately 50 patients
Title
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
Time Frame
End of study
Title
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
Time Frame
End of Study
Title
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.
Time Frame
during the hospital stay
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 minimum 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;
Target lesions treatable with 4mm stent (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 remains above normal at the time of treatment;
Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
Documented Left ventricular ejection fraction 25%;
Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauri Laura, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
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