MASCOT - Post Marketing Registry (MASCOT)

July 31, 2017 updated by: OrbusNeich

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients who undergo PCI with (attempted) placement of at least one Combo Stent as part of routine clinical care are entered into the registry. PCI with a Combo Stent is considered attempted when the operator has passed the Combo Stent across the guiding catheter.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjudicated device-oriented composite target lesion failure (TLF)
Time Frame: 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.
12 months post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Adjudicated TLF
Time Frame: at index procedure, 30 days, 6 months and 12 months post procedure
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))
Time Frame: at index procedure, 30 days, 6 months, 12 months
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)
Time Frame: at index procedure, 30 days, 6 months and 12 months
at index procedure, 30 days, 6 months and 12 months
Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)
Time Frame: at index procedure, 30 days, 6 months and 12 months
at index procedure, 30 days, 6 months and 12 months
Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition
Time Frame: at index procedure, 30 days, 6 months and 12 months post-procedure
at index procedure, 30 days, 6 months and 12 months post-procedure
Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition
Time Frame: at index procedure, 30 days, 6 months and 12 months post-procedure
at index procedure, 30 days, 6 months and 12 months post-procedure
Adjudicated stroke
Time Frame: at index procedure, 30 days, 6 months and 12 months
at index procedure, 30 days, 6 months and 12 months
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
Time Frame: Index Procedure
Index Procedure
Procedure success: Successful stent placement and no peri-procedural complications.
Time Frame: Index procedure
Index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

April 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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