MASCOT - Post Marketing Registry

Coronary Artery Disease Clinical Trial

— MASCOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183454
• Other study ID #: VP-0639
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: July 31, 2017
• Start date: June 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: April 2017
• Source: OrbusNeich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amphia Ziekenhuis	Breda

Sponsors (2)

Lead Sponsor	Collaborator
OrbusNeich	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated device-oriented composite target lesion failure (TLF)	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.	12 months post procedure
Secondary	Adjudicated TLF		at index procedure, 30 days, 6 months and 12 months post procedure
Secondary	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
Secondary	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
Secondary	Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)		at index procedure, 30 days, 6 months and 12 months
Secondary	Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition		at index procedure, 30 days, 6 months and 12 months post-procedure
Secondary	Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition		at index procedure, 30 days, 6 months and 12 months post-procedure
Secondary	Adjudicated stroke		at index procedure, 30 days, 6 months and 12 months
Secondary	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
Secondary	Procedure success: Successful stent placement and no peri-procedural complications.		Index procedure