MASCOT - Post Marketing Registry
NCT02183454 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2500
Last updated 2017-08-01
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 order to assess the long term safety and performance of the Combo Stent in routine clinical practice.
Conditions
Interventions
- DEVICE
-
OrbusNeich COMBO stent
The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
collaborator OTHER -
OrbusNeich
lead INDUSTRY
Principal Investigators
-
Antonio Colombo, MD · San Raffaele Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2017-05-31
- Completion
- 2017-05-31
Countries
- Netherlands
Study Locations
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