Phase 3
Completed N=100
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
Source: ClinicalTrials.gov NCT00231283 ↗Enrolled (actual)
100
Serious AEs
1.1%
Results posted
Mar 2010
Primary outcomePrimary: Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge — 97 Percentage of Participants
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 with de novo native coronary artery lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge |
97 | — |
| SECONDARY Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later |
3.0 | — |
| SECONDARY Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge |
3.0 | — |
| SECONDARY Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later |
10.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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;
Data sourced from ClinicalTrials.gov (NCT00231283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.