SELUTION 4 De Novo Small Vessel IDE Trial

NCT05946629 | Active Not Recruiting DMC FDA Device

• 1 other identifier: SEL-003-2021
• Study Type: interventional
• Target: 960
• Locations: 3 countries
• Sites: 70

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

CAD; DCB; DEB; NSTEMI; Stable Angina; Chronic Coronary Syndrome; CCS; Drug Coated Balloons; Drug Eluting Balloons; Small Vessels; SELUTIONSLR; Sirolimus

Outcome Measures

Primary Outcomes (5)

• Target lesion failure (TLF)

  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

  PK parameters of C(max)

  6 months

• PK Sub-study Primary Endpoint 2

  PK parameters of T(max)

  6 months

• PK Sub-study Primary Endpoint 3

  PK parameters of AUC(last)

  6 months

• PK Sub-study Primary Endpoint 4

  PK parameters of MRT(last)

  6 months

Secondary Outcomes (17)

• Secondary Endpoint 1

  12 months

• Secondary Endpoint 2

  Up to 7 days

• Secondary Endpoint 3

  Up to 7 days

• Secondary Endpoint 4

  Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

• Secondary Endpoint 5

  Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

Other Outcomes (8)

• PK Sub-Study Secondary Endpoint 1

  6 months

• PK Sub-Study Secondary Endpoint 2

  6 months

• PK Sub-Study Secondary Endpoint 3

  6 months

Study Arms (2)

SELUTION SLR 014 PTCA DEB

EXPERIMENTAL

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

Control Treatment

ACTIVE COMPARATOR

any FDA approved "limus-based" Drug Eluting Stent, as per standard institutional practice

Device: PCI with FDA approved "-limus" DES

Interventions

PCI with SELUTION SLR DCB DEVICE

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.

SELUTION SLR 014 PTCA DEB

PCI with FDA approved "-limus" DES DEVICE

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.

Control Treatment

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all of the following clinical criteria to participate in the trial:
• Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
• Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
• 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.
• 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).
• Subject has life expectancy \> 1 year in the opinion of the investigator.
• Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
• \. 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.
• Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:
• 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.
• 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.
• Target lesion is ≤ 36 mm in length.
• Target lesion has diameter stenosis \> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.
• Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \[by visual assessment\].
• Target lesion is within a native coronary artery or major branch.

You may not qualify if:

• Subjects who meet any of the following clinical criteria will be excluded from the trial:
• Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
• Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
• 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.
• Subject with PCI of a non-target vessel within ± 30 days of the index procedure.
• Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
• 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).
• Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
• Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%.
• Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
• Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
• Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.
• 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.

Sponsors & Collaborators

• M.A. Med Alliance S.A.: lead
• NAMSA: collaborator
• Cordis US Corp.: collaborator

Study Sites (70)

St. Bernards

Jonesboro, Arkansas, 72401, United States

Location

CISD Sharp Chula Vista

Chula Vista, California, 91911, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

HCA Los Robles

Thousand Oaks, California, 91360, United States

Location

Harbor UCLA

Torrance, California, 90502, United States

Location

Colorado Heart and Vascular

Golden, Colorado, 80401, United States

Location

ClinRe

Thornton, Colorado, 80023, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial

Bradenton, Florida, 34208, United States

Location

Mease Countryside Hospital

Clearwater, Florida, 34695, United States

Location

University of Florida, Jacksonville

Jacksonville, Florida, 32209, United States

Location

HCA Largo

Largo, Florida, 33770, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

HCA Northside

St. Petersburg, Florida, 33709, United States

Location

HCA Trinity

Trinity, Florida, 34655, United States

Location

Atlanta VA

Atlanta, Georgia, 30033, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

Hamilton Medical Center

Dalton, Georgia, 30720, United States

Location

Archbold Memorial Hospital

Thomasville, Georgia, 31792, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

University of Iowa Medical Center

Iowa City, Iowa, 52242, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess

Boston, Massachusetts, 02114, United States

Location

Mass General

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

HCA Overland Park

Overland Park, Missouri, 66211, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Englewood Health

Englewood, New Jersey, 07631, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Northwell Health Lenox Hill

New York, New York, 10075, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

NC Heart and Vascular

Raleigh, North Carolina, 27607, United States

Location

The Lindner Research Center at Christ

Cincinnati, Ohio, 45219, United States

Location

UH Cleveland

Cleveland, Ohio, 44120, United States

Location

Oklahoma Heart

Oklahoma City, Oklahoma, 73120, United States

Location

Penn State Health Hershey & Berks

Hershey, Pennsylvania, 17033, United States

Location

UPMC Pinnacle

Mechanicsburg, Pennsylvania, 17050, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

Lifespan Rhode Island & Miriam

Providence, Rhode Island, 02903, United States

Location

CHI Memorial

Chattanooga, Tennessee, 37404, United States

Location

University of Nebraska

Chattanooga, Tennessee, 37404, United States

Location

HCA Centennial

Nashville, Tennessee, 37203, United States

Location

Hendrick Health

Abilene, Texas, 79601, United States

Location

Texas Health

Dallas, Texas, 75231, United States

Location

Baylor Scott and White - Dallas

Dallas, Texas, 75246, United States

Location

Medical City of Fort Worth

Fort Worth, Texas, 76104, United States

Location

Baylor Scott and White Plano

Plano, Texas, 75093, United States

Location

Baylor Scott and White - Temple

Temple, Texas, 76508, United States

Location

Intermountain Health - Salt Lake City

Murray, Utah, 84107, United States

Location

HCA Chippenham

Richmond, Virginia, 23225, United States

Location

CAMC

Charleston, West Virginia, 25304, United States

Location

Advocate Aurora St. Luke's

Milwaukee, Wisconsin, 53215, United States

Location

ZOL Genk

Genk, 3600, Belgium

Location

Hartcentrum Hasselt Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Universitäts-Herzzentrum Freiburg

Bad Krozingen, 79189, Germany

Location

UKB Berlin

Berlin, 12683, Germany

Location

Herzzentrum Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Non-ST Elevated Myocardial Infarction; Angina, Stable

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The randomized trial is a single-blind study. The physician performing the index procedure as well as study site personnel present at the index procedure will not be blinded, however every effort will be made to maintain blinding for the following: * Subjects and their families * Site personnel involved in conducting study assessments during follow-up Unblinding will only occur to protect subject rights, welfare, or well-being. The angiographic and pK substudy cohorts will not be blinded. The Clinical Events Committee (CEC) will be blinded to the treatment arm during the adjudication process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-Blind Randomized Control Trial

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 14, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

US (65); DE (3); BE (2)