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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00231257 |
The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions.
Condition | Intervention | Phase |
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In-Stent Restenosis |
Device: Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent Procedure: Brachytherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized Study of the Sirolimus-Eluting Bx VELOCITY® BALLOON Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients With In-Stent Restenotic Coronary Artery Lesions |
Enrollment: | 384 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | September 2009 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Cypher Bx Velocity
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Device: Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
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2: Active Comparator
Brachytherapy
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Procedure: Brachytherapy
Brachytherapy
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. The patient has an in-stent restenosis of > 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.
2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
3. The study target lesion must be located in an in-stent restenotic native coronary artery measuring > 2.75mm and 3.5mm in diameter and > 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary interventional treatment > 4 weeks previously. Patients with one or more prior percutaneous coronary interventions at the target lesion are acceptable candidates.
4. The vessel 1cm distal to the target lesion is > 2.5mm in diameter;
5. Ejection Fraction must be > 40%;
6. The study target lesion cannot be located in a vessel containing a second lesion requiring treatment at the time of the procedure.
7. Male or non-pregnant female patients > 18 years of age inclusive. NOTE: Females of child-bearing potential must have a negative pregnancy test (urine or serum) prior to enrollment and must use birth control for 6 months.
Exclusion Criteria:
United States, Minnesota | |
Mayo Clinic Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | David R. Holmes, Jr., MD | Mayo Clinic Rochester, Minnesota |
Responsible Party: | Mayo Clinic Rochester, Minnesota ( David R. Holmes, Jr., MD ) |
Study ID Numbers: | P02-6313 |
Study First Received: | September 30, 2005 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00231257 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sirolimus Anti-Bacterial Agents Immunologic Factors Clotrimazole |
Miconazole Antifungal Agents Tioconazole Immunosuppressive Agents |
Sirolimus Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |