Coronary Artery DiseaseSMART-INCT07811024
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).
A study testing Sirolimus-coated balloon catheter in people with Coronary Artery Disease and Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Tonic Medical, Inc. at 2 sites in Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- 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
- What is being tested?
- Sirolimus-coated balloon catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUzbekistan
- Study dates
- 12 Aug 2026to May 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Any non-target lesions to be treated during the index procedure have been successfully treated
- Meets the additional Inclusion criteria for the corresponding arm
- 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
- Confirmed stent expansion ≥ 80% of distal reference vessel diameter by angiography and there is no malposed stent struts
- Eligible for treatment in the ISR arm with one of the ten largest device sizes
- Reference vessel diameter is ≥ 2.0 mm and ≤ 2.75 mm
Who cannot join
- 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
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- 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
- Patient is a recipient of a heart transplant
- Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, or contrast agent
- History of allergic reaction or sensitivity to sirolimus or other analogue or derivative
- Known hypersensitivity to excipients with phospholipid or related origins and Poly(lactic-co-glycolic acid) (PLGA)
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a white blood cell count of <3,000 cells/mm3
- Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output
- Subject with history of New York Heart Association (NYHA) class III or IV heart failure
- History of bleeding diathesis, active peptic ulcer or GI bleeding within prior 6 months or coagulopathy or will refuse blood transfusions
- Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
- History of a stroke within 6 months prior to the index procedure
- Concurrent life conditions with a life expectancy of less than 24 months
- In Investigator's opinion, the patient is not a good candidate for the study
- Left ventricular ejection fraction < 30%
- Unprotected left main coronary artery disease with ≥ 50% stenosis
- Target lesion at a bifurcation Note: A target lesion near a bifurcation is allowed if only a single vessel (either main vessel or side branch) is to be treated
- Evidence of extensive thrombus or dissection in target lesion
- Chronic total occlusion (CTO) in target lesion
- >30% residual stenosis after pre-treatment of target lesion
- Target lesion is located in the left main or within any arterial or venous graft
- Target lesion is in a side branch that is "jailed" by a main vessel stent
- > 50% stenosis of an additional proximal lesion or clinically significant distal lesion (in a vessel >2.0mm RVD) to the target or non-target lesion
- Target vessel is excessively tortuous, defined as more than one bend > 90° to reach target lesion
- Target lesion is the 3rd or greater stent failure (i.e., more than two [2] layers of stent are present at any segment of the target lesion)
- Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure
- If single-layer ISR, any previous treatment (other than balloon angioplasty alone) of the target vessel for restenosis If double-layer ISR, any treatment (other than balloon angioplasty alone) of the double-layer ISR restenosis
- Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including any non-target lesion treated during the index procedure
- The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason
- Subject is taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plans to take the strong inhibitors during the study period (Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir)
- Subject is taking strong CYP3A4 Inducers within 14 days before the index procedure or plans to take the strong inducers during the study period (Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort)
- Type C lesion
- Calcified or angular target lesion which cannot be pre-dilated with high pressure balloons, scoring balloon or IVL
- In-stent restenosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jill Moland contact
Uzbekistan2 sites, 2 recruiting
- Recruiting
Republican Research Centre of Emergency Medicine
Tashkent, 100052
Study Coordinator, d.ibragimov@clinaccelerator.com
Farrukh Djalalov
- Recruiting
Republican Specialized Scientific and Practical Medical Center of Cardiology
Tashkent, 100052
Study Coordinator, d.ibragimov@clinaccelerator.com
Khurshid Fozilov, MD, PhD
About this study
Official title: SMART-I: SiroMax™ Multi-Center Coronary Artery Lesion Treatment - Safety and Feasibility Study of SiroMax SCB in ISR and 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.
Read the detailed description
This is a prospective, multicenter, open label clinical trial which is being conducted at up to 8 clinical sites outside the United States. Up to 60 subjects will be treated in the clinical trial.
The ISR arm will enroll and treat up to 30 subjects, and the DNSV arm will enroll and treat up to an additional 30 subjects. A subset of at least 15 subjects in the ISR arm will be enrolled in a pharmacokinetic (PK) sub-study to assess the elimination profile of the drug.
The primary safety endpoint is the incidence of device- and/or procedure-related Major Adverse Cardiac Events (MACEs) through 30 days, 6 months, and 12 months post-procedure, for which a MACE is defined as a composite of any of the following complications:
- Cardiac Death
- Non-fatal Myocardial Infarction
- Non-fatal stroke
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
All subjects will undergo angiographic assessment during the index procedure per standard of care. A maximum of one non-target lesion in a non-target vessel may be treated with commercially available devices during the study index procedure. The non-target lesion must be treated during the index procedure and deemed an angiographic success prior to enrollment and treatment of the target lesion.
Only one target lesion may be treated with the study device.
All enrolled subjects who receive a study device will be evaluated through hospital discharge and at 30 days, 3 months, 6 months, 12 months, then annually through 5 years post index procedure. Subjects in the PK sub-study will have an additional follow-up visit at 7 days post procedure.
- 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
- Being tested
- Sirolimus-coated balloon catheter
- Keywords
- Tonic Medical, SMART, SiroMax, Sirolimus, DCB, SCB, coated balloon, SMART-I, SMART-1, SMART1
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus-coated balloon catheterCombination product
Also called SiroMax, Drug-coated balloon, Drug coated balloon, SCB
Treatment of an ISR lesion with the SiroMax Sirolimus Coated Balloon
Sirolimus-coated balloon catheterCombination product
Also called SiroMax, SCB, DCB, Drug-coated balloon
Treatment of a DNSV lesion with the SiroMax Sirolimus Coated Balloon
| Study group | Role | What they receive |
|---|---|---|
| In-stent Restenosis (ISR) | Experimental | The ISR arm includes a Pharmacokinetic Sub-study of 15 subjects Receives: Combination Product: Sirolimus-coated balloon catheter |
| De Novo Small Vessel (DNSV) | Experimental | Not described Receives: Combination Product: Sirolimus-coated balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start12 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tonic Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Accelerator
- Responsible party
- Sponsor
- Investigators
- Eric A Secemsky, MD, MSc, RPVI, FACC, FAHA, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811024
- Sponsor's protocol ID
- CLN1001-001
- Acronym
- SMART-I
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD collected throughout the trial will be available to be shared upon reasonable request.