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

NCT ID: NCT00231283

Last Updated: 2010-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2005-07-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System

Group Type: EXPERIMENTAL

CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)

Intervention Type: DEVICE

CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordis

Principal Investigators

Emerson Perin, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Heart Institute

Locations

Texas Heart Institute

Houston, Texas, United States

Countries

United States

Other Identifiers

P04-6324

Identifier Type: -

Identifier Source: org_study_id