NCT02183454

MASCOT - Post Marketing Registry

Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (actual)
• Sponsor: OrbusNeich · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 (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.

Conditions

• Coronary Artery Disease
• Atherosclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2014-07-08
• Last updated: 2017-08-01

Locations

1 site across 1 country: Netherlands