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Completed

NCT Number: NCT02183454

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amphia Ziekenhuis

Breda, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

OrbusNeich COMBO stent

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adjudicated TLF

    Time frame: at index procedure, 30 days, 6 months and 12 months post procedure

  2. 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

  3. 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

  4. 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

  5. Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition

    Time frame: at index procedure, 30 days, 6 months and 12 months post-procedure

  6. Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition

    Time frame: at index procedure, 30 days, 6 months and 12 months post-procedure

  7. Adjudicated stroke

    Time frame: at index procedure, 30 days, 6 months and 12 months

  8. 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

  9. Procedure success: Successful stent placement and no peri-procedural complications.

    Time frame: Index procedure

Sponsors and collaborators

Lead sponsor

OrbusNeich

Industry

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

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

Acronym: MASCOT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2014
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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