Status:
COMPLETED
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- Male or non-pregnant female patients 18 years of age
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
- Treatment of a single de novo target lesion in a major native coronary artery;
- Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
- Target lesion is 30mm in length (visual estimate);
- Target lesion stenosis is \> 50% and \< 100% (visual estimate);
Exclusion
- 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;
- Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
- Significant (\> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
- Documented Left ventricular ejection fraction 25%;
- Totally occluded vessel (TIMI 0 level);
- Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00231283
Start Date
April 1 2004
End Date
July 1 2005
Last Update
April 20 2010
Active Locations (1)
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1
Texas Heart Institute
Houston, Texas, United States, 77030