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Clinical trial

A Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9TM Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM)

NCT04079192 is registered in ClinicalTrials.gov with Biosensors Europe SA as lead sponsor.

NCT NCT04079192
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Registry record

As filed in ClinicalTrials.gov.

Title
A Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9TM Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM)
Lead sponsor
Biosensors Europe SA
Phase
Not applicable
Overall status
Unknown status
Start date
August 7, 2020
Completion date
April 30, 2024
Enrollment
201 (actual)
Sites
15

Conditions

As the registry lists them; a condition with its own page is linked.

coronary artery disease, in-stent restenosis