MASCOT - Post Marketing Registry

NCT02183454 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2017-08-01

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02183454 on ClinicalTrials.gov