NCT04966273

Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS

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) - BIOMICS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Biosensors, the Sponsor would like to determine if the Biosensors Microcatheter is safe and effective in treating patients with CTO by assessing a composite of in-hospital cardiac death or myocardial infarction and device success (defined as successfully facilitate placement of a guidewire beyond the occluded coronary segment), respectively.

Detailed description

Prospective, multi-center, open-label single-arm trial designed to enroll 100 patients undergoing attempted CTO-PCI at up to 10 centers in the United Kingdom and N. Ireland. For assessment of efficacy, the ability of the BM to successfully facilitate placement of a guidewire beyond the occluded coronary segment will be assessed. Patients will be followed up until hospital discharge or 7 days post index procedure, whichever comes first. For the assessment of safety, the incidence of in-hospital cardiac death or myocardial infarction will be assessed at hospital discharge or 7 days post index procedure, whichever comes first.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	Microcatheter	Only to be used if Biosensor Microcatheter does not perform accordingly

Timeline

• Start date: 2022-03-18
• Primary completion: 2023-01-03
• Completion: 2023-01-03
• First posted: 2021-07-19
• Last updated: 2023-01-18

Locations

9 sites across 1 country: United Kingdom