Status:
COMPLETED
Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 nativ...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00233779
Start Date
October 1 2003
End Date
December 1 2004
Last Update
June 27 2007
Active Locations (1)
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1
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil