MASCOT - Post Marketing Registry

Status Completed

Clinical Trial 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.

Clinical Trial 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 (according to the Instructions for use) as part of routine clinical care. Approximately 2,500 patients from 50 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for one year. The registry is considered finished when all patients have completed the 12 month follow-up.

A follow-up is scheduled at 30 days, 6 months and 12 months post procedure. Follow-up is obtained at a planned regular visit to the outpatient clinic, or by telephone contact with the patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02183454
Study type	Observational [Patient Registry]
Source	OrbusNeich
Contact
Status	Completed
Phase	N/A
Start date	June 2014
Completion date	May 31, 2017

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MASCOT - Post Marketing Registry — MASCOT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms