NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)

• Registration Number: NCT00231283
• Lead Sponsor: Cordis Corporation

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 with de novo native coronary artery lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-07
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Results First Submitted: 2008-11-18
• Results First Submitted QC: 2010-03-11
• Results First Posted: 2010-03-23
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-13
• Last Update Posted: 2010-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or non-pregnant female patients 18 years of age
2. 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;
3. Treatment of a single de novo target lesion in a major native coronary artery;
4. Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
5. Target lesion is 30mm in length (visual estimate);
6. Target lesion stenosis is > 50% and < 100% (visual estimate);

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)	CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge	From post-procedure up to hospital discharge	Procedure Success is defined as the final residual diameter stenosis \< 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later	From post-procedure up to 30 days	Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge	From post-procedure up to hospital discharge	Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later	From post-procedure up to 12 months	Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).

Trial Locations

Locations (1)

Texas Heart Institute; 🇺🇸 Houston, Texas, United States