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Sponsored by: |
Cordis Corporation |
---|---|
Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00231283 |
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions |
Estimated Enrollment: | 100 |
Study Start Date: | April 2004 |
Study Completion Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1. 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 remain above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
3. Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Documented Left ventricular ejection fraction 25%;
5. Totally occluded vessel (TIMI 0 level);
6. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Study ID Numbers: | P04-6324 |
Study First Received: | September 30, 2005 |
Last Updated: | May 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00231283 |
Health Authority: | United States: Food and Drug Administration |
Sirolimus Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |