Status: Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults. Participants will be screened to determine if they meet the eligibility requirements for the study. Eligible participants who provide informed consent will receive treatment with the study device and be followed for 5 years.
Participants needed: 60
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: Tonic Medical, Inc.Updated: Sep 14, 2026Locations: 2
Eligibility criteria
Age ≥ 21 years [+18]
Pregnant or nursing patients [+46]