BioFreedom US IDE Feasibility Trial

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.

Clinical Trial Description

This is a multi-center prospective trial of 100 patients at up to 15 centers. The study population will consist of patients preventing with symptomatic ischemic heart disease due to de novo stenotic lesion(s) in native coronary artery(ies) with reference vessel diameter between 2.25 mm and 4.0 mm.

The primary safety endpoint for this clinical trial is the occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis within 9 months following the implantation.

The primary effectiveness endpoint for this trial is in-stent late lumen loss at 9 months as compared to historical control ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02131142
Study type	Interventional
Source	Biosensors Europe SA
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	August 2014
Completion date	July 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Active, not recruiting	`NCT04562805` - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)	N/A
Recruiting	`NCT05292079` - CAPTURER PMCF Study ( rEPIC04D )
Recruiting	`NCT05292014` - ANGIOLITE PMCF Study ( rEPIC04F )
Recruiting	`NCT05292092` - Essential Pro PMCF Study ( rEPIC04E )
Recruiting	`NCT05292118` - Navitian PMCF Study ( rEPIC04C )
Completed	`NCT05292105` - NC Xperience PMCF Study( rEPIC04B)
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Not yet recruiting	`NCT04153383` - Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting	`NCT02729064` - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose	Phase 1
Recruiting	`NCT02982434` - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation	Phase 2
Completed	`NCT02468401` - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions	N/A
Completed	`NCT02759406` - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study	N/A
Recruiting	`NCT01681381` - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization	N/A
Completed	`NCT01699802` - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)	N/A
Completed	`NCT01604213` - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease	Phase 4
Completed	`NCT01334268` - RESOLUTE China RCT	N/A
Completed	`NCT01724567` - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training	N/A
Completed	`NCT02159235` - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)	N/A