Back to resultsSirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
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 patient minimum 18 years of age There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon; Target lesion is 2.50mm and 3.50mm in diameter (visual estimate); Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents; Exclusion Criteria: There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy; The study target lesion has definite or possible thrombus present by angiographic criteria.
Sites / Locations
- Scripps Clinic and Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
CYPHER Sirolimus-Eluting Coronary Stent
Outcomes
Primary Outcome Measures
The primary endpoint of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00231244
Brief Title
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
Official Title
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
November 2008 (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 allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.
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
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CYPHER Sirolimus-Eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
CYPHER Sirolimus-Eluting Coronary Stent
Intervention Description
CYPHER Sirolimus-Eluting Coronary Stent
Primary Outcome Measure Information:
Title
The primary endpoint of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years.
Time Frame
30 days, 6mo, 12mo, 2, 3, 4, and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant female patient minimum 18 years of age
There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;
Exclusion Criteria:
There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy;
The study target lesion has definite or possible thrombus present by angiographic criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Teirstein, MD
Organizational Affiliation
Scripps Clinic and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic and Research
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16079441
Citation
Costa M, Angiolillo DJ, Teirstein P, Gilmore P, Leon M, Moses J, Yakubov S, Carter A, Fischell T, Zenni M, Bass T. Sirolimus-eluting stents for treatment of complex bypass graft disease: insights from the SECURE registry. J Invasive Cardiol. 2005 Aug;17(8):396-8.
Results Reference
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Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
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