Status:
UNKNOWN
Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent
Lead Sponsor:
Robbert J de Winter
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open ov...
Detailed Description
Registry Investigated Device: The OrbusNeich Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable...
Eligibility Criteria
Inclusion
- Consecutive patients eligible for Combo stent placement by percutaneous coronary intervention are included in the REMEDEE REGISTRY
Exclusion
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
- A life expectancy of \<1 year
- Explicit refusal of participation in the registry
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01874002
Start Date
June 1 2013
End Date
March 1 2019
Last Update
December 30 2015
Active Locations (9)
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1
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
2
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
3
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands, 1105AZ
4
Ter Gooi Ziekenhuizen
Blaricum, Netherlands