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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00231283
First received: September 30, 2005
Last updated: April 13, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge [ Time Frame: From post-procedure up to hospital discharge ] [ Designated as safety issue: Yes ]
    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:
  • Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later [ Time Frame: From post-procedure up to 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From post-procedure up to hospital discharge ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From post-procedure up to 12 months ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 100
Study Start Date: April 2004
Study Completion Date: July 2005
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231283

Locations
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Emerson Perin, MD Texas Heart Institute
  More Information

No publications provided

Responsible Party: Sidney Cohen, MD, PhD, Vice President, Cordis
ClinicalTrials.gov Identifier: NCT00231283     History of Changes
Other Study ID Numbers: P04-6324
Study First Received: September 30, 2005
Results First Received: November 18, 2008
Last Updated: April 13, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014