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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014