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MASCOT - Post Marketing Registry (MASCOT)

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ClinicalTrials.gov Identifier: NCT02183454
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Atherosclerosis Device: OrbusNeich COMBO stent

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry
Study Start Date : June 2014
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183454


Locations
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Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Sponsors and Collaborators
OrbusNeich
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Antonio Colombo, MD San Raffaele Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: OrbusNeich
ClinicalTrials.gov Identifier: NCT02183454    
Other Study ID Numbers: VP-0639
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: April 2017
Keywords provided by OrbusNeich:
intracoronary stent
drug eluting stent
sirolimus
endothelial progenitor cells
Additional relevant MeSH terms:
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Coronary Artery Disease
Atherosclerosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases