Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
1 other identifier
interventional
252
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Mar 2002
Longer than P75 for phase_3 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedDecember 7, 2009
December 1, 2009
6.2 years
October 3, 2005
December 4, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30 days, 6mo, 12mo, 2, 3, 4, and 5 years
Study Arms (1)
1
EXPERIMENTALCYPHER Sirolimus-Eluting Coronary Stent
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cordis US Corp.lead
Study Sites (1)
Scripps Clinic and Research
La Jolla, California, 92037, United States
Related Publications (1)
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.
PMID: 16079441BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Teirstein, MD
Scripps Clinic and Research
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 4, 2005
Study Start
March 1, 2002
Primary Completion
May 1, 2008
Study Completion
November 1, 2008
Last Updated
December 7, 2009
Record last verified: 2009-12