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

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ClinicalTrials.gov Identifier: NCT00231283
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : March 23, 2010
Last Update Posted : April 20, 2010
Sponsor:
Information provided by:
Cordis Corporation

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2004
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge [ Time Frame: From post-procedure up 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


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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).

  3. 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 ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sidney Cohen, MD, PhD, Vice President, Cordis
ClinicalTrials.gov Identifier: NCT00231283     History of Changes
Other Study ID Numbers: P04-6324
First Posted: October 4, 2005    Key Record Dates
Results First Posted: March 23, 2010
Last Update Posted: April 20, 2010
Last Verified: April 2010

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