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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cordis Corporation

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Study Completion (ACTUAL): July 1, 2005

Study Registration Dates

• First Submitted: September 30, 2005
• First Submitted That Met QC Criteria: September 30, 2005
• First Posted (ESTIMATE): October 4, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2010
• Last Update Submitted That Met QC Criteria: April 13, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: P04-6324