Overview

This trial is active, not recruiting.

Conditions coronary artery disease, atherosclerosis
Treatment orbusneich combo stent
Sponsor OrbusNeich
Collaborator Icahn School of Medicine at Mount Sinai
Start date June 2014
End date March 2017
Trial size 2500 participants
Trial identifier NCT02183454, VP-0639

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Adjudicated device-oriented composite target lesion failure (TLF)
time frame: 12 months post procedure

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry
Principal investigator Antonio Colombo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by OrbusNeich.