MASCOT - Post Marketing Registry (MASCOT)

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Sponsors and Collaborators

OrbusNeich

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Antonio Colombo, MD; San Raffaele Hospital

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chandrasekhar J, Sartori S, Aquino MB, Baber U, Hájek 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, 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). 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;:.

• Responsible Party: OrbusNeich
• ClinicalTrials.gov Identifier: NCT02183454
• Other Study ID Numbers: VP-0639
• First Posted: July 8, 2014
• 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:

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