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| Sponsor: | Cordis Corporation |
|---|---|
| Information provided by: | Cordis Corporation |
| ClinicalTrials.gov Identifier: | NCT00231283 |
Purpose
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 |
Eligibility| 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;
Contacts and Locations
More Information
| Study ID Numbers: | P04-6324 |
| Study First Received: | September 30, 2005 |
| Last Updated: | May 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00231283 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |