Other Clinical Trial - Asian Registry of the BioFreedom Stent for STEMI

Status Completed

Clinical Trial Summary

The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia. The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of a specific group of patients; patients with a myocardial infarction (STEMI). The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of these STEMI patients.

Clinical Trial Description

The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of STEMI patients. The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of STEMI patients. This will be a fully observational post market registry designed to enroll 1000 STEMI patients at about 20 centers in up to 8 Asian countries where the BioFreedom BA9 (SS) DCS is available for clinical use. The primary endpoint is LTF, which is a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization. The investigators expect event rates of the composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization to be 4.3% at one year as observed in the COMFORTABLE AMI study. Assuming a one-sided type I error (α) of 0.025, and a non-inferiority margin of 1.9%, a cohort of 1000 patients will have more than 80% power to conclude non-inferiority. The complete data analysis will be described in a Statistical Analysis Plan (SAP) that will be finalized and signed before the one year database lock. Primary and secondary endpoint related events will be adjudicated by independent adjudicators. The study will be monitored per a monitoring plan, data will be collected in an electronic data capture system. All enrolled patients will be followed up at 1, 4 and 12 months to collect information on their current status, review of cardiac medication taken and any adverse events that they have experienced. Both CERC and Biosensors will follow company SOP's which are GCP and ISO 14155:2011 compliant. ;

Study Design

Related Conditions & MeSH terms

Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
STEMI - ST Elevation Myocardial Infarction

Clinical Trial Details

NCT number	NCT03609346
Study type	Observational [Patient Registry]
Source	Biosensors Europe SA
Contact
Status	Completed
Phase
Start date	November 22, 2018
Completion date	August 5, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Asian Registry of the BioFreedom Stent for STEMI Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms