- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183454
MASCOT - Post Marketing Registry (MASCOT)
Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Breda, Netherlands
- Amphia Ziekenhuis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
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
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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.
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12 months post procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adjudicated TLF
Time Frame: at index procedure, 30 days, 6 months and 12 months post procedure
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at index procedure, 30 days, 6 months and 12 months post procedure
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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
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at index procedure, 30 days, 6 months, 12 months
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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
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at index procedure, 30 days, 6 months and 12 months
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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
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at index procedure, 30 days, 6 months and 12 months
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Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition
Time Frame: at index procedure, 30 days, 6 months and 12 months post-procedure
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at index procedure, 30 days, 6 months and 12 months post-procedure
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Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition
Time Frame: at index procedure, 30 days, 6 months and 12 months post-procedure
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at index procedure, 30 days, 6 months and 12 months post-procedure
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Adjudicated stroke
Time Frame: at index procedure, 30 days, 6 months and 12 months
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at index procedure, 30 days, 6 months and 12 months
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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
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Index Procedure
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Procedure success: Successful stent placement and no peri-procedural complications.
Time Frame: Index procedure
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Index procedure
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Chandrasekhar J, Sartori S, Aquino MB, Baber U, Hajek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iniguez A, Coufal Z, Khashaba A, Schee A, Munawar M, Gerber RT, Yan BP, Tejedor P, Kala P, Liew HB, Lee M, Kalkman DN, Dangas GD, de Winter RJ, Colombo A, Mehran R; MASCOT investigators (Appendix I). Comparison of One-Year Outcomes in Patients >75 Versus </=75 Years With Coronary Artery Disease Treated With COMBO Stents (From The MASCOT Registry). Am J Cardiol. 2020 Jul 15;127:1-8. doi: 10.1016/j.amjcard.2020.04.014. Epub 2020 Apr 24.
- Chandrasekhar J, Kerkmeijer LS, Kalkman DN, Sartori S, Aquino MB, Woudstra P, Beijk MA, Tijssen JG, Koch KT, Hajek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iniguez A, Coufal Z, Khashaba A, Munawar M, Gerber RT, Yan BP, Lee M, Baber U, Dangas GD, Colombo A, de Winter RJ, Mehran R; MASCOT and REMEDEE investigators (full list of collaborators shown in the Appendix). Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration. Catheter Cardiovasc Interv. 2021 Apr 1;97(5):797-804. doi: 10.1002/ccd.28853. Epub 2020 Mar 21.
- Chandrasekhar J, Kalkman DN, Aquino MB, Sartori S, Hajek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iniguez A, Coufal Z, Khashaba A, Schee A, Munawar M, Gerber RT, Yan BP, Tejedor P, Kala P, Liew HB, Lee M, Baber U, Vogel B, Dangas GD, Colombo A, de Winter RJ, Mehran R; MASCOT; REMEDEE investigators (Appendix I in the Supplementary material). 1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration. Int J Cardiol. 2020 May 15;307:17-23. doi: 10.1016/j.ijcard.2020.01.045. Epub 2020 Jan 24.
- Colombo A, Chandrasekhar J, Aquino M, Ong TK, Sartori S, Baber U, Lee M, Iniguez A, Hajek P, Borisov B, Atzev B, Den Heijer P, Coufal Z, Hudec M, Mates M, Snyder C, Moalem K, Morrell D, Elmore F, Rowland S, Mehran R; MASCOT Investigators. Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry. Int J Cardiol. 2019 May 15;283:67-72. doi: 10.1016/j.ijcard.2019.01.053. Epub 2019 Jan 21. Erratum In: Int J Cardiol. 2019 Jun 18;:
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VP-0639
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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