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).

NCT07811024 | Recruiting FDA Device

• 1 other identifier: CLN1001-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

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; PTCA; PCI; Stenosis Coronary; Stenosis Artery; Stenotic Coronary Lesion

Keywords

Tonic Medical; SMART; SiroMax; Sirolimus; DCB; SCB; coated balloon; SMART-I; SMART-1; SMART1

Outcome Measures

Primary Outcomes (4)

• The primary efficacy endpoint is the target lesion failure (TLF) rate at 6 months

  TLF is defined as: * Cardiac death * Ischemia-driven target lesion revascularization (TLR) * Target vessel myocardial infarction (MI) * Spontaneous MI: * Periprocedural MI:

  6 months post treatment

• Incidence of device- and/or procedure-related Major Adverse Cardiac Events (MACEs) through 30 days post procedure

  MACE is defined as a composite of any of the following complications: * Cardiac Death * Non-fatal Myocardial Infarction * Non-fatal stroke

  30 days post procedure

• Incidence of device- and/or procedure-related Major Adverse Cardiac Events (MACEs) through 6 months post procedure

  MACE is defined as a composite of any of the following complications: * Cardiac Death * Non-fatal Myocardial Infarction * Non-fatal stroke

  6 months post procedure

• Incidence of device- and/or procedure-related Major Adverse Cardiac Events (MACEs) through 12 months post-procedure

  MACE is defined as a composite of any of the following complications: * Cardiac Death * Non-fatal Myocardial Infarction * Non-fatal stroke

  12 months post procedure

Study Arms (2)

In-stent Restenosis (ISR)

EXPERIMENTAL

The ISR arm includes a Pharmacokinetic Sub-study of 15 subjects

Combination Product: Sirolimus-coated balloon catheter

De Novo Small Vessel (DNSV)

EXPERIMENTAL

Combination Product: Sirolimus-coated balloon catheter

Interventions

Sirolimus-coated balloon catheter COMBINATION_PRODUCT

Treatment of an ISR lesion with the SiroMax Sirolimus Coated Balloon

Also known as: SiroMax, Drug-coated balloon, Drug coated balloon, SCB, DCB, Sirolimus coated balloon, Sirolimus-eluting balloon

In-stent Restenosis (ISR)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years
• Provided written informed consent
• If a woman of child-bearing potential, agrees to use a reliable method of contraception from the time of screening through 12 months after the index procedure
• Diagnosed with symptomatic ischemic heart disease, stable or unstable angina with signs of ischemia, silent ischemia, or a positive function test
• Eligible for percutaneous coronary intervention (PCI)
• Able to tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor
• Any non-target lesions to be treated during the index procedure have been successfully treated
• Target lesion \> 50% and \< 100% stenosed by QCA in symptomatic patients, and \> 70% and \< 100% stenosed in asymptomatic patients prior to lesion pre-treatment
• Distal TIMI grade flow of 3
• Target lesion must be ≤ 26mm length
• Successful pre-treatment of the target lesion
• Target lesion is within a native coronary artery or major branch
• Reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm
• Restenosis of stented coronary artery (Includes BMS and DES). The target lesion may have been treated with no more than 2 stents
• Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent

You may not qualify if:

• Pregnant or nursing patients
• Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable
• Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure
• Subject with planned major surgery within 30 days following the index procedure
• Subject with planned treatment of lesion involving aorto-ostial location
• History of previous target vessel perforation
• Cardiogenic shock
• Patients with lesions requiring interventional treatment in more than two vessels
• Extensive peripheral vascular disease that precludes safe sheath insertion
• Ostial lesion or planned future treatments
• Diffuse disease distal to target lesion with impaired runoff
• Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated
• Previous PCI of target vessel within 6 months prior to the procedure
• Planned PCI of any vessel within 30 days post index procedure and/or planned PCI of the target vessel within 12 months post procedure
• Currently participating or planning to participate, within 24 months of the index procedure, in an investigational drug or device trial

Sponsors & Collaborators

• Tonic Medical, Inc.: lead
• Clinical Accelerator: collaborator

Study Sites (2)

Republican Research Centre of Emergency Medicine

Tashkent, 100052, Uzbekistan

RECRUITING

Republican Specialized Scientific and Practical Medical Center of Cardiology

Tashkent, 100052, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Eric A Secemsky, MD, MSc, RPVI, FACC, FAHA

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Central Study Contacts

Chief Operating Officer

CONTACT

1-612-425-4668; barnettp@tonicmedical.com

Jill Moland

CONTACT

molandj@tonicmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study has two arms (ISR and DNSV) and includes a PK sub-study in the ISR arm. All enrolled subjects will receive the same intervention, regardless of the arm.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2032
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning at the time of results reporting and ending 1 year after the publication of results

Locations

UZ (2)