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

NCT00231283 | Completed Phase 3 Results

• 1 other identifier: P04-6324
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later

  From post-procedure up to 30 days

• Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge

  From post-procedure up to hospital discharge

• Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later

  From post-procedure up to 12 months

Study Arms (1)

1

EXPERIMENTAL

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)

Interventions

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

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 100% (visual estimate);

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Texas Heart Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Sidney Cohen, MD PhD, Vice President
• Organization: Cordis

scohen7@its.jnj.com

650 614-2726

Study Officials

• Emerson Perin, MD

  Texas Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: April 1, 2004
• Study Completion: July 1, 2005
• Last Updated: April 20, 2010
• Results First Posted: March 23, 2010

Record last verified: 2010-04

Locations

US (1)