Clinical trial NCT02183454: MASCOT - Post Marketing Registry
Official title: Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: intracoronary stent
drug eluting stent
sirolimus
endothelial progenitor cells
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2014-07-08
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Adjudicated device-oriented composite target lesion failure (TLF)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Adjudicated TLF
timeFrame: at index procedure, 30 days, 6 months and 12 months post procedure
measure: Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))
timeFrame: at index procedure, 30 days, 6 months, 12 months
measure: 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)
timeFrame: at index procedure, 30 days, 6 months and 12 months
measure: Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)
timeFrame: at index procedure, 30 days, 6 months and 12 months
measure: Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition
timeFrame: at index procedure, 30 days, 6 months and 12 months post-procedure
measure: Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition
timeFrame: at index procedure, 30 days, 6 months and 12 months post-procedure
measure: Adjudicated stroke
timeFrame: at index procedure, 30 days, 6 months and 12 months
measure: 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
timeFrame: Index Procedure
measure: Procedure success: Successful stent placement and no peri-procedural complications.
timeFrame: Index procedure
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
Study officials:
affiliation: San Raffaele Hospital
name: Antonio Colombo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.