Biosensors BIOMICS Study 20-EU-01
Research type
Research Study
Full title
A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO)
IRAS ID
302843
Contact name
James C S Spratt
Contact email
Sponsor organisation
Biosensors Europe S.A.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CI/2021/0046/GBNI, MHRA reference number; 21/LO/0626, REC reference number
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Research Summary
This study is being run to assess the safety and effectiveness of a new device called a microcatheter, that is used during the opening of a completely closed heart artery during a process called percutaneous cardiac intervention (PCI). The patients included in this study have a heart artery that is completely closed (chronic total occlusion (CTO)) and thus the process to open up this closure is called CTP-PCI. The new device is a microcatheter that helps pass the guide wire (used to put a stent or balloon in place to open up the artery) across the totally closed part of the artery. One hundred (100) patients where CTO has been diagnosed by their cardiologists, are being included in the study at up to 6 centres in the UK. All patients that have read the information sheet and have singed the consent form will be treated with the investigative device and will be followed up for any safety events until they are being discharged from hospital or up to 7 days if they have to stay longer. The results of this study will be used to get approval to sell the device in the EU.
Summary of results
The device showed a success rate of 75% for placement of the guidewire in the vessel across the occluded coronary segment and demonstrated superior efficacy compared to the performance goal of 54%.
Regarding the safety assessment of the study device as per the clinical evaluation committee, there were no death, revascularization or stent thrombosis reported up to discharge. 2 myocardial infarctions were reported.
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0626
Date of REC Opinion
11 Nov 2021
REC opinion
Further Information Favourable Opinion