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).
SMART-I: SiroMax™ Multi-Center Coronary Artery Lesion Treatment - Safety and Feasibility Study of SiroMax SCB in ISR and DNSV
Tonic Medical, Inc.
60 participants
Aug 12, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Treatment of an ISR lesion with the SiroMax Sirolimus Coated Balloon
Treatment of a DNSV lesion with the SiroMax Sirolimus Coated Balloon
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07811024