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Trial record 67 of 172 for:    "Heart Disease" | "Heparin"

Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233779
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : June 27, 2007
Information provided by:
Cordis Corporation

Brief Summary:
The objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™ stent.

Condition or disease Intervention/treatment Phase

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sirolimus-Eluting, Heparin-Coated Cobalt Chromium Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels (EVOLUTION)
Study Start Date : October 2003
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Primary Outcome Measures :
  1. The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure. [ Time Frame: 6 months post-procedure ]

Secondary Outcome Measures :
  1. In-lesion late loss as measured by QCA at 6 months post-procedure. [ Time Frame: 6 months post-procedure ]
  2. In-stent and in-lesion minimum lumen diameter (MLD) and percent diameter stenosis (%DS) by QCA post-procedure and at 6 months. [ Time Frame: Post-procedure and at 6 months ]
  3. Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
  4. Target Lesion Revascularization (TLR) at six and 12 months. [ Time Frame: 6 and 12 months ]
  5. Target Vessel Revascularization (TVR) at six and 12 months. [ Time Frame: 6 and 12 months ]
  6. Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months and 12 months post-procedure. [ Time Frame: 30 days, 6 months and 12 months post-procedure ]
  7. Stent Lumen and Stent Obstruction Volume by Intravascular Ultrasound (IVUS) at post procedure and six months follow-up. [ Time Frame: post procedure and six months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient must be minimum 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-III) OR patients with documented silent ischemia;

3 Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;

4. The target lesion is >/=2.0 mm and </=2.5mm in diameter (visual estimate);

5. The target lesion can be covered with a single 18mm stent;

6. Target lesion stenosis is >50% and <100% (TIMI I) (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. Target lesion is due to in-stent restenosis;
  3. Ejection fraction 30%;
  4. Totally occluded vessel (TIMI 0 level);
  5. Impaired renal function (creatinine > 3.0 mg/dL);

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 identifier (NCT number): NCT00233779

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Instituto Dante Pazzanese de Cardiologia
Sao Paolo, Brazil
Sponsors and Collaborators
Cordis Corporation
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Principal Investigator: J. E. Sousa, MD Instituto Dante Pazzanese de Cardiologia

Layout table for additonal information Identifier: NCT00233779     History of Changes
Other Study ID Numbers: P03-7401
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: June 27, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Heart Diseases
Calcium heparin
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs