Home › Trials › NCT05946629

Treatment for small coronary vessel lesions using a new drug-coated balloon

A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels

Not applicable Interventional M.A. Med Alliance S.A. · NCT05946629

This study is testing a new drug-coated balloon to see if it works better than a standard stent for treating small coronary vessel blockages in people who have heart issues.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment960 (estimated)
Ages18 Years and up
SexAll
SponsorM.A. Med Alliance S.A. Industry-sponsored
Drugs / interventionsceritinib
Locations43 sites (Jonesboro, Arkansas and 42 other locations)
Trial IDNCT05946629 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the SELUTION SLR 014 PTCA drug-coated balloon (DEB) for treating de novo lesions in small coronary vessels, specifically those with a reference vessel diameter of 2.00 mm to 2.75 mm. The study is a prospective, randomized controlled, single-blind trial involving up to 910 subjects across multiple sites in the US, Canada, Brazil, Japan, and Europe. Participants will be randomized to receive either the SELUTION DEB or a contemporary drug-eluting stent (DES) after undergoing percutaneous coronary intervention (PCI). The trial aims to support a pre-market approval application to the US FDA.

Who should consider this trial

Good fit: Ideal candidates include adults with chronic coronary syndromes, unstable angina, or stabilized non-ST elevation myocardial infarction who require PCI for small vessel lesions.

Not a fit: Patients with larger coronary vessel lesions or those who cannot tolerate dual antiplatelet therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for patients with small coronary vessel lesions.

How similar studies have performed: Other studies using drug-coated balloons for coronary interventions have shown promising results, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Clinical Inclusion Criteria

Subjects must meet all of the following clinical criteria to participate in the trial:

1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
3. Subject presents with chronic coronary syndromes \[CCS\] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.
4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).
5. Subject has life expectancy \> 1 year in the opinion of the investigator.
6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.

PK Sub- Study Inclusion Criteria:

Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria:

1\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations.

Imaging Inclusion Criteria

Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:

1. A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment \> 30 days from the index procedure.
2. Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion.
3. Target lesion is ≤ 36 mm in length.
4. Target lesion has diameter stenosis \> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.
5. Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \[by visual assessment\].
6. Target lesion is within a native coronary artery or major branch.
7. A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.
8. The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment.

Exclusion Criteria:

* Clinical Exclusion Criteria

Subjects who meet any of the following clinical criteria will be excluded from the trial:

1. Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
4. Subject with planned major surgery within 30 days following the index procedure.
5. Subject with planned treatment of lesion involving aorto-ostial location.
6. Subject with PCI of a non-target vessel within ± 30 days of the index procedure.
7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).
9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
10. Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%.
11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.
14. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or had undergone renal transplantation.

PK Sub-Study Exclusion Criteria:

Subjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met:

1. 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 non-target lesion(s) treated during the index procedure.
2. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \>30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.
3. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.
4. Subject is concurrently enrolled in the main protocol angiographic registry.
5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan 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.
6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan 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.

   * Angiographic Exclusion Criteria

Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:

1. Target lesion is totally occluded or has evidence of thrombus.
2. Target lesion is located in the left main or any arterial or venous graft.
3. Target lesion is in a side branch that is "jailed" by a main vessel stent.
4. In stent restenosis

Where this trial is running

Jonesboro, Arkansas and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseCADDCBDEBNSTEMIStable AnginaChronic Coronary SyndromeCCS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.