Status:
UNKNOWN
Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions
Lead Sponsor:
R&D Cardiologie
Collaborating Sponsors:
Biotronik SE & Co. KG
Conditions:
Coronary Artery Disease
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark reduction in res...
Detailed Description
A total of 330 patients are randomized to either hybrid sirolimus-eluting stent or everolimus-eluting stent after successful recanalization of TCO. Clinical follow-up at 1, 6, 12 months, 2, 3, 4, 5 ye...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- the estimated duration of the occlusion is at least 4 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 :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01516723
Start Date
February 1 2012
End Date
May 1 2020
Last Update
March 28 2017
Active Locations (4)
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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
St Antonius Hospital
Nieuwegein, Netherlands, 3435CM