SELUTION 4 De Novo Small Vessel IDE Trial

September 25, 2025 updated by: M.A. Med Alliance S.A.

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

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.

The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized controlled, single-blind, multicenter, clinical trial

The study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Subjects who present with chronic coronary syndrome (CCS), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) with an indication for percutaneous coronary intervention (PCI) with planned intervention for de novo lesions in small coronary vessels (RVD 2.00 mm to 2.75 mm) and meeting all eligibility criteria will be randomized 1:1 to treatment of the identified target lesion with either the SELUTION SLR 014 PTCA DEB or contemporary DES.

Randomized Cohort:

  • Intervention (DEB Strategy): Subjects randomized to the SELUTION SLR 014 PTCA DEB arm will receive lesion preparation according to the 3rd drug coated balloon (DCB) consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, intravascular lithotripsy, laser, rotational or orbital atherectomy, cutting or scoring balloon at the discretion of the operator as needed to reduce diameter stenosis to ≤ 30%). Subjects with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30%) will receive a DES instead of the SELUTION DEB but remain in the SELUTION DEB group (intention to treat analysis). The DEB should not be used after DES implant.
  • Control (DES): Subjects randomized to the DES arm will receive treatment using any FDA approved "limus-based" DES, as per standard institutional practice.

Angiographic Substudy:

The angiographic substudy is a parallel registry consisting of up to 30 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. These subjects will undergo angiography at 12 months post-procedure. Clinical follow-up will not extend beyond 12 months in this cohort.

Pharmacokinetic (pK) Substudy:

The pKsubstudy is a parallel registry consisting of up to 20 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. This study will be conducted under an approved substudy protocol and will include blood draws at regular intervals to characterize the pK plasma profile of sirolimus.

Primary Endpoint:

Target lesion failure (TLF), defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months. MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SELUTION SLR 014 PTCA DEB

SELUTION Sustained Limus Release (SLR) 014 Percutaneous Transluminal Coronary Angioplasty (PTCA) Drug Eluting Balloon (DEB)

The SELUTION SLR 014 PTCA DEB is a minimally invasive, single use and sterile Sirolimus coated PTCA balloon catheter.

The SELUTION SLR 014 PTCA DEB is available with balloon diameters from 2.0 to 3.0 mm and lengths of 15 to 40 mm for the purpose of the De Novo IDE trial
Device: PCI with SELUTION SLR DCB
After target lesion pre-dilatation and preparation , a SELUTION SLR 014 PTCA DEB study device should be selected with nominal diameter equal to the RVD of the target lesion (1:1 ratio) and length that allows approximately 2.00 mm longer than the proximal and distal edges of the target lesion (defined as the proximal and distal extent of predilation). If IVUS is performed to assess RVD, and DEB upsizing is deemed clinically necessary for optimal results, a maximum nominal DEB diameter of 3.0 mm is permitted. The SELUTION SLR 014 PTCA DEB should then be delivered, positioned in and deployed per instructions per use. The balloon should be inflated for 60 seconds provided that the patient can tolerate this duration. The minimum inflation time is 30 seconds.
Active Comparator: Control Treatment
any FDA approved "limus-based" Drug Eluting Stent, as per standard institutional practice
Device: PCI with FDA approved "-limus" DES

For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.

The DES should be sized per IFU with respect to the vessel RVD. The use of IVUS or OCT is encouraged to guide optimal stent placement and assess final results. After DES deployment, additional balloon inflations should be performed as needed to obtain < 30% residual diameter stenosis and resolve proximal or distal edge dissections greater than or equal to NHLBI grade B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure (TLF)
Time Frame: 12 months

Target lesion failure (TLF) is defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months.

MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.
12 months
PK Sub-study Primary Endpoint 1
Time Frame: 6 months
PK parameters of C(max)
6 months
PK Sub-study Primary Endpoint 2
Time Frame: 6 months
PK parameters of T(max)
6 months
PK Sub-study Primary Endpoint 3
Time Frame: 6 months
PK parameters of AUC(last)
6 months
PK Sub-study Primary Endpoint 4
Time Frame: 6 months
PK parameters of MRT(last)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint 1
Time Frame: 12 months
Composite of all-cause mortality, target vessel MI or clinically driven target lesion revascularization
12 months
Secondary Endpoint 2
Time Frame: Up to 7 days
Lesion success, defined as attainment of < 30% residual stenosis of target lesion using any percutaneous method
Up to 7 days
Secondary Endpoint 3
Time Frame: Up to 7 days
Procedure success, defined as attainment of < 30% residual stenosis of the target lesion using the assigned study device only without the occurrence of in-hospital major adverse cardiac events (MACE), composite of all-cause death, MI or any clinically-driven TLR.
Up to 7 days
Secondary Endpoint 4
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Composite safety endpoint, defined as the patient-oriented composite of any death, any MI (spontaneous or peri-procedural), or any repeat revascularization.
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 5
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
All-Cause Mortality
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 6
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Cardiovascular Mortality
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 7
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
MI (spontaneous MI using the 4th UDMI, peri-procedural MI using SCAI and Academic Research Consortium [ARC]-2 definitions)
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 8
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Clinically-driven TLR
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 9
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
all TLR
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 10
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Clinically-driven Target Vessel Revascularization (TVR)
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 11
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
all TVR
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 12
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Non-target lesion revascularization
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 13
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
TLF
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 14
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Target vessel failure (TVF), defined as a composite of: cardiac death, target vessel MI (spontaneous or peri-procedural) and any clinically-driven TVR
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 15
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Stent or target lesion segment thrombosis (definite or probable) according to the ARC criteria for acute, subacute, late, very late and cumulative stent thrombosis
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Secondary Endpoint 16
Time Frame: 12 months
Bleeding Academic Research Consortium (BARC) class 2-5
12 months
Secondary Endpoint 17
Time Frame: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Net adverse clinical events, defined as death, MI (spontaneous or peri-procedural), TVR, stent/target lesion segment thrombosis or bleeding (BARC types 2-5, assessed to 12 months)
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK Sub-Study Secondary Endpoint 1
Time Frame: 6 months
If calculations are valid, additional PK parameter of AUC(inf).
6 months
PK Sub-Study Secondary Endpoint 2
Time Frame: 6 months
If calculations are valid, additional PK parameter of Cl.
6 months
PK Sub-Study Secondary Endpoint 3
Time Frame: 6 months
If calculations are valid, additional PK parameter of Vz.
6 months
PK Sub-Study Secondary Endpoint 4
Time Frame: 6 months
If calculations are valid, additional PK parameter of Vss.
6 months
PK Sub-Study Secondary Endpoint 5
Time Frame: 6 months
If calculations are valid, additional PK parameter of half-life.
6 months
PK Sub-Study Secondary Endpoint 6
Time Frame: 6 months
Dose normalized C(max) will be considered if appropriate.
6 months
PK Sub-Study Secondary Endpoint 7
Time Frame: 6 months
Dose normalized AUC will be considered if appropriate.
6 months
PK Sub-Study Secondary Endpoint 8
Time Frame: 6 months
Device success, defined as attainment of ≤ 30% residual stenosis of the target lesion using the assigned device only
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.A. Med Alliance S.A.

Collaborators

Cordis Corporation
NAMSA

Investigators

  • Principal Investigator: Ron Waksman, MD, Medstar Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEL-003-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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