Health TrialsbyHealthPanel

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).

ConditionsCoronary Artery DiseaseCoronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))In-Stent Restenosis or De Novo Coronary Artery LesionsIn-Stent Stenosis (Restenosis) of Coronary Artery StentSmall Vessel DiseaseCAD - Coronary Artery DiseaseCADCAD PatientsPTCAPCIStenosis CoronaryStenosis ArteryStenotic Coronary Lesion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorTonic Medical, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Sirolimus-coated balloon catheter

    Combination product

    Treatment of an ISR lesion with the SiroMax Sirolimus Coated Balloon

  • Sirolimus-coated balloon catheter

    Combination product

    Treatment of a DNSV lesion with the SiroMax Sirolimus Coated Balloon

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: In-stent Restenosis (ISR)Experimental treatment 1 intervention
Group B: De Novo Small Vessel (DNSV)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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:

Time frame
6 months post treatment
2

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

Time frame
30 days post procedure
3

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

Time frame
6 months post procedure
4

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

Time frame
12 months post procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tonic Medical, Inc.

Lead sponsor

Clinical Accelerator

Collaborator

Source ClinicalTrials.gov
Apply now