Status:
COMPLETED
Sirolimus-eluting vs Zotarolimus-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 coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon a...
Detailed Description
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) was traditionally limited by high restenosis rates. Coronary stenting using bare metal stents significantly decreases resteno...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- the estimated duration of the occlusion is at least 2 weeks.
- signs of ischemia related to the occluded coronary artery.
- successful recanalization of the occluded artery is achieved.
- reference diameter is \> 2.5 mm.
- written informed consent obtained.
- EXCLUSION CRITERIA
- primary or rescue PCI for acute myocardial infarction
- the lesion could not be crossed.
- lesions with complex anatomy making successful stent deployment unlikely.
- the guide wire is not in the true lumen distal to the occlusion.
- Sirolimus or zotarolimus allergy
- venous or arterial bypass grafts
- pregnant or nursing women.
- participation in an other trial.
- factors making long-term follow-up difficult or unlikely.
- life expectancy \<1 year.
- contraindications for ASA or Clopidogrel or heparin.
- use of coumadins that could not be stopped before the procedure.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00428454
Start Date
January 1 2007
End Date
June 1 2015
Last Update
June 4 2015
Active Locations (5)
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1
AZ Middelheim
Antwerp, Antwerpen, Belgium, 2020
2
AMC
Amsterdam, Amsterdam, Netherlands, 1105AZ
3
Catharina Ziekenhuis
Eindhoven, Eindhoven, Netherlands, 5602ZA
4
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1090HM