Status:
COMPLETED
Sirolimus-Eluting Stents for Chronic Total Coronary Occlusions
Lead Sponsor:
R&D Cardiologie
Collaborating Sponsors:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplast...
Detailed Description
Since data from the 2 landmark studies, the BENESTENT and STRESS studies, showed that coronary stenting significantly decreases restenosis as compared with conventional balloon angioplasty, this treat...
Eligibility Criteria
Inclusion
- Estimated duration of the chronic total coronary occlusion of at least two weeks
- Evidence of ischemia related to the target vessel (signs of ischemia during an abnormal exercise test, defined as ST depression of at least 1.0 mm that is horizontal or down-sloping or up-sloping ST depression of at least 2.0 mm or signs of ischemia found during nuclear imaging with exercise, dobutamine or adenosine).
Exclusion
- The lesion could not be crossed
- The use of heparin, aspirin and clopidogrel was prohibited
- Severe renal failure (creatinine\>250µmol/L)
- Patients were unwilling or unable to complete follow-up.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00258596
Start Date
January 1 2003
End Date
September 1 2006
Last Update
March 6 2007
Active Locations (2)
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1
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1090HM
2
St Antonius Hospital
Nieuwegein, Netherlands, 3435CM