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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231283
• Other study ID #: P04-6324
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: April 13, 2010
• Start date: April 2004
• Est. completion date: July 2005

Study information

• Verified date: April 2010
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Texas Heart Institute	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Procedure Success From Post-procedure 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	From post-procedure up to hospital discharge	Yes
Secondary	Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later	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).	From post-procedure up to 30 days	Yes
Secondary	Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure 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).	From post-procedure up to hospital discharge	Yes
Secondary	Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later	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).	From post-procedure up to 12 months	Yes