Status:
COMPLETED
Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent
Lead Sponsor:
Raul Moreno
Conditions:
Coronary Artery Disease
Coronary Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Chronic total coronary occlusions (CTO) have an especially high risk of angiographic restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES) have demonstrated to ...
Eligibility Criteria
Inclusion
- Patients ≥ 18 year-old.
- A total occlusion (TIMI 0-1) with an estimated time of occlusion \> 2 weeks.
- Symptomatic or silent ischaemia, or viable myocardium.
- The occlusion is suitable for percutaneous coronary intervention.
- The guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device.
Exclusion
- Acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study.
- The lesion can not be crossed with the guidewire and balloon angioplasty.
- The vessel has been previously treated percutaneously.
- The lesion is not suitable for a 2.25-3.5 coronary stent implantation.
- The patient is not willing to undergo an angiographic follow-up.
- The patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months.
- Pregnancy or absence of pregnancy test in women of childbearing age.
- Chronic renal failure (creatinine plasmatic values \> 3.0 mg/dl).
- Plasmatic platelet count \< 100.000 mm-3 or \> 700.000 mm-3.
- The patient has a severe non-cardiac disease that limits his/her life expectancy to \< 1 year.
- The patient is currently included in other randomized trial.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00793221
Start Date
November 1 2008
Last Update
June 19 2012
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