MASCOT - Post Marketing Registry (MASCOT)
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| ClinicalTrials.gov Identifier: NCT02183454 |
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Recruitment Status :
Completed
First Posted : July 8, 2014
Last Update Posted : August 1, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Artery Disease Atherosclerosis | Device: OrbusNeich COMBO stent |
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 : | 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 |
- 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.
- 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.
- Adjudicated TLF [ Time Frame: at index procedure, 30 days, 6 months and 12 months post procedure ]
- 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 ]
- 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 ]
- 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 ]
- Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition [ Time Frame: at index procedure, 30 days, 6 months and 12 months post-procedure ]
- Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition [ Time Frame: at index procedure, 30 days, 6 months and 12 months post-procedure ]
- Adjudicated stroke [ Time Frame: 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 [ Time Frame: Index Procedure ]
- Procedure success: Successful stent placement and no peri-procedural complications. [ Time Frame: Index procedure ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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
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
| Netherlands | |
| Amphia Ziekenhuis | |
| Breda, Netherlands | |
| Principal Investigator: | Antonio Colombo, MD | San Raffaele Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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intracoronary stent drug eluting stent sirolimus endothelial progenitor cells |
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Coronary Artery Disease Atherosclerosis Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |