MASCOT - Post Marketing Registry

Conditions

Atherosclerosis, Coronary Artery Disease

Keywords

intracoronary stent, drug eluting stent, sirolimus, endothelial progenitor cells

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.

Chandrasekhar J, Kok MM, Kalkman DN, Aquino MB, Zocca P, Woudstra P, Beijk MA, Kerkmeijer LS, Sartori S, Baber U, Tijssen JG, Koch KT, Dangas GD, Colombo A, Pocock S, von Birgelen C, Mehran R, de Winter RJ, COMBO Collaborators and BIO-RESORT Investigators.

2020-04-018 citations

10.1016/j.jcin.2019.11.023

1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration.

Chandrasekhar J, Kalkman DN, Aquino MB, Sartori S, Hájek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iñiguez 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).

2020-01-242 citations

10.1016/j.ijcard.2020.01.045

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.

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.

2019-01-2116 citations

10.1016/j.ijcard.2019.01.053

1-Year Clinical Outcomes of All-Comer Patients Treated With the Dual-Therapy COMBO Stent: Primary Results of the COMBO Collaboration.

de Winter RJ, Chandrasekhar J, Kalkman DN, Aquino MB, Woudstra P, Beijk MA, Sartori S, Baber U, Tijssen JG, Koch KT, Dangas GD, Colombo A, Mehran R, MASCOT, REMEDEE Registry Investigators.

2018-10-0115 citations

10.1016/j.jcin.2018.04.038

Interventions

DEVICEOrbusNeich 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Adjudicated device-oriented composite target lesion failure (TLF)	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

Measure	Time frame
Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))	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)	at index procedure, 30 days, 6 months and 12 months
Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)	at index procedure, 30 days, 6 months and 12 months
Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition	at index procedure, 30 days, 6 months and 12 months post-procedure
Adjudicated TLF	at index procedure, 30 days, 6 months and 12 months post procedure
Adjudicated stroke	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	Index Procedure
Procedure success: Successful stent placement and no peri-procedural complications.	Index procedure
Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition	at index procedure, 30 days, 6 months and 12 months post-procedure

Countries

Netherlands

Outcome results

None listed