Status:
COMPLETED
MASCOT - Post Marketing Registry
Lead Sponsor:
OrbusNeich
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
Brief Summary
To collect post marketing surveillance data on patients receiving at least one Combo Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data will be collected in o...
Detailed Description
The multicenter, multinational, prospective registry population consists of patients who undergo percutaneous coronary intervention (PCI) with (attempted) placement of at least one Combo Stent (accord...
Eligibility Criteria
Inclusion
- In general, consecutive patients are included in the registry. Patients are only excluded from registration if ANY of the following conditions apply:
- Undergoing PCI for treatment of stent thrombosis
- 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 \<12 months
- Explicit refusal of participation in the registry
Exclusion
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT02183454
Start Date
June 1 2014
End Date
May 31 2017
Last Update
August 1 2017
Active Locations (1)
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1
Amphia Ziekenhuis
Breda, Netherlands