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NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
This study has been completed.
First Received: September 30, 2005   Last Updated: May 2, 2007   History of Changes
Sponsor: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00231283
  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 III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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:
  • Final residual diameter stenosis < 50% by Quantatative 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:
  • Composite of MACE defined as death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR) at discharge and 30 days post-procedure. [ Time Frame: Discharge and 30 days post-procedure ]

Estimated Enrollment: 100
Study Start Date: April 2004
Study Completion Date: July 2005
  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

Study ID Numbers: P04-6324
Study First Received: September 30, 2005
Last Updated: May 2, 2007
ClinicalTrials.gov Identifier: NCT00231283     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 09, 2009