Back to resultsEvaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: The patient must be minimum 18 years of age; 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: 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; Target lesion is due to in-stent restenosis; Ejection fraction 30%; Totally occluded vessel (TIMI 0 level); Impaired renal function (creatinine > 3.0 mg/dL);
Sites / Locations
- Instituto Dante Pazzanese de Cardiologia
Outcomes
Primary Outcome Measures
The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233779
Brief Title
Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)
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 Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
In-lesion late loss as measured by QCA at 6 months post-procedure.
Time Frame
6 months post-procedure
Title
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
Title
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.
Title
Target Lesion Revascularization (TLR) at six and 12 months.
Time Frame
6 and 12 months
Title
Target Vessel Revascularization (TVR) at six and 12 months.
Time Frame
6 and 12 months
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must be minimum 18 years of age;
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:
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;
Target lesion is due to in-stent restenosis;
Ejection fraction 30%;
Totally occluded vessel (TIMI 0 level);
Impaired renal function (creatinine > 3.0 mg/dL);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. E. Sousa, MD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paolo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)
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