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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).

Study acronym: SMART-I
StatusRecruiting
PhaseNot applicable
Started2026-08-12
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07811024
Lead Sponsor Tonic Medical, Inc.
Collaborators: Clinical Accelerator
Conditions Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Small Vessel Disease, CAD - Coronary Artery Disease, CAD, CAD Patients +5 more
Enrollment 60 participants
Start Date 2026-08-12
Primary Completion 2028-05 (estimated)
Study Completion 2032-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-14