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

October 4, 2005
June 26, 2007
October 2003
Not Provided
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 ]
The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure.
Complete list of historical versions of study NCT00233779 on ClinicalTrials.gov Archive Site
  • 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 ]
  • · In-lesion late loss as measured by QCA at 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.
  • · 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.
  • · Target Vessel Revascularization (TVR) at six 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.
  • · Stent Lumen and Stent Obstruction Volume by Intravascular Ultrasound (IVUS) at post procedure and six months follow-up.
Not Provided
Not Provided
 
Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)
Sirolimus-Eluting, Heparin-Coated Cobalt Chromium Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels (EVOLUTION)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
December 2004
Not Provided

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);
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00233779
P03-7401
No
Not Provided
Cordis Corporation
Not Provided
Principal Investigator: J. E. Sousa, MD Instituto Dante Pazzanese de Cardiologia
Cordis Corporation
June 2007

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