MASCOT - Post Marketing Registry

Completed

• Conditions: Coronary Artery Disease; Atherosclerosis

• Registration Number: NCT02183454
• Lead Sponsor: OrbusNeich

Brief 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Status Verified: 2017-04
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adjudicated device-oriented composite target lesion failure (TLF)	12 months post procedure	Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting (CABG)) at 12 months post procedure.

Secondary Outcome Measures

Name	Time	Method
Adjudicated stroke	at index procedure, 30 days, 6 months and 12 months
Adjudicated TLF	at index procedure, 30 days, 6 months and 12 months post procedure
Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))	at index procedure, 30 days, 6 months, 12 months
Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) as a composite of all Death, any MI and ischemia-driven revascularization (TLR/TVR/non-TVR)	at index procedure, 30 days, 6 months and 12 months
Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)	at index procedure, 30 days, 6 months and 12 months
Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition	at index procedure, 30 days, 6 months and 12 months post-procedure
Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition	at index procedure, 30 days, 6 months and 12 months post-procedure
Device success: Percentage of patients with a successful delivery and deployment of the Combo Stent to the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation	Index Procedure
Procedure success: Successful stent placement and no peri-procedural complications.	Index procedure

Trial Locations

Locations (1)

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands