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

September 30, 2005
May 2, 2007
April 2004
 
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
Same as current
Complete list of historical versions of study NCT00231283 on ClinicalTrials.gov Archive Site
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 ]
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.
 
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.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Coronary Artery Disease
Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
July 2005
 

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;

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231283
 
P04-6324
Cordis Corporation
 
Principal Investigator: Emerson Perin, MD Texas Heart Institute
Cordis Corporation
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP