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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233779
First received: October 4, 2005
Last updated: June 26, 2007
Last verified: June 2007
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT
Phase 2

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: Sirolimus-Eluting, Heparin-Coated Cobalt Chromium Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels (EVOLUTION)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • 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:
  • In-lesion late loss as measured by QCA at 6 months post-procedure. [ Time Frame: 6 months post-procedure ]
  • 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 ]
  • 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.
  • Target Lesion Revascularization (TLR) at six and 12 months. [ Time Frame: 6 and 12 months ]
  • Target Vessel Revascularization (TVR) at six and 12 months. [ Time Frame: 6 and 12 months ]
  • 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 ]
  • 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 ]

Enrollment: 52
Study Start Date: October 2003
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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);
  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: NCT00233779

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

No publications provided

ClinicalTrials.gov Identifier: NCT00233779     History of Changes
Other Study ID Numbers: P03-7401
Study First Received: October 4, 2005
Last Updated: June 26, 2007
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
Calcium heparin
Heparin
Sirolimus
Everolimus
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014