NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
Completed · Phase 3
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT00231283
- Run by
- Cordis US Corp.
- People needed
- 100
- Starts
- 2004-04-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2010-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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);
You may not qualify if…
- 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;
Where it is running
- Texas Heart Institute — Houston, Texas, United States
Full record on ClinicalTrials.gov
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