MASCOT - Post Marketing Registry

OrbusNeich

Status: Completed

Conditions: Coronary Artery Disease; Atherosclerosis

Treatments: Device: OrbusNeich COMBO stent

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02183454

VP-0639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

In general, consecutive patients are included in the registry. Patients are only excluded from registration if ANY of the following conditions apply:

1. Undergoing PCI for treatment of stent thrombosis
2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
3. Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
4. A life expectancy of <12 months
5. Explicit refusal of participation in the registry