Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
NCT ID: NCT00231244
Last Updated: 2009-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
252 participants
INTERVENTIONAL
2002-03-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent
Interventions
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CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent
Eligibility Criteria
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Inclusion Criteria
2. There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
3. Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
4. Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;
Exclusion Criteria
2. The study target lesion has definite or possible thrombus present by angiographic criteria.
18 Years
ALL
No
Sponsors
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Cordis Corporation
INDUSTRY
Responsible Party
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Cordis
Principal Investigators
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Paul Teirstein, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Clinic and Research
Locations
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Scripps Clinic and Research
La Jolla, California, United States
Countries
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References
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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.
Other Identifiers
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P01-6310
Identifier Type: -
Identifier Source: org_study_id