Actively Recruiting
SELUTION 4 De Novo Small Vessel IDE Trial
Led by M.A. Med Alliance S.A. · Updated on 2025-09-29
960
Participants Needed
43
Research Sites
397 weeks
Total Duration
On this page
Sponsors
M
M.A. Med Alliance S.A.
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SELUTION 4 De Novo Small Vessel IDE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or minimum legal age by local rules)
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before procedure or use contraception
- Diagnosis of chronic coronary syndromes, unstable angina, or stabilized NSTEMI with planned PCI
- Able to tolerate dual antiplatelet therapy with aspirin plus Clopidogrel, Prasugrel, or Ticagrelor
- Life expectancy greater than 1 year per investigator
- Willing and able to provide informed consent and follow study procedures
- Target lesion treatable in a single vessel with no non-target lesions treated in the same vessel during index procedure
- Up to two non-target lesions in other vessels may be treated before randomization
- Target lesion length 36 mm or less
- Target lesion diameter stenosis greater than 50% and less than or equal to 99% with sufficient blood flow
- Target vessel reference diameter between 2.00 mm and 2.75 mm
- Target lesion within native coronary artery or major branch
- Bifurcation lesions allowed if only one vessel treated
- Target lesion assessed as likely to be successfully treated with approved techniques and DEB alone
- For PK sub-study, must also consent and comply with PK procedures
You will not qualify if you...
- Known allergy or hypersensitivity to sirolimus or similar drugs
- NSTEMI with rising biomarkers, ongoing chest pain, or unstable condition
- History of STEMI within 30 days prior to procedure
- Planned major surgery within 30 days after procedure
- Planned treatment of lesions in aorto-ostial locations
- PCI of a non-target vessel within 30 days before or after procedure
- History of severe heart failure (NYHA class III or IV) within 6 months
- Active peptic ulcer or gastrointestinal bleeding within 6 months or inability to comply with dual antiplatelet therapy
- Pregnant, breastfeeding, or planning pregnancy within 1 year after procedure
- Left ventricular ejection fraction below 30%
- Unable to tolerate at least 30 seconds of coronary occlusion
- Participating in another investigational drug or device study without completed primary endpoint follow-up
- Active COVID-19 infection at time of procedure
- Severe kidney failure requiring dialysis or recent renal transplant
- For PK sub-study, prior or planned use of any limus-eluting device within defined timeframes
- Use of strong CYP3A4 inhibitors or inducers within 14 days before procedure or planned during study
- Target lesion totally occluded or with thrombus
- Lesion in left main artery or arterial/venous graft
- Lesion in side branch jailed by a stent
- In stent restenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 43 locations
1
St. Bernards
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
CISD Sharp Chula Vista
Chula Vista, California, United States, 91911
Actively Recruiting
3
Cedars Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
4
HCA Los Robles
Thousand Oaks, California, United States, 91360
Actively Recruiting
5
Harbor UCLA
Torrance, California, United States, 90502
Actively Recruiting
6
Colorado Heart and Vascular
Golden, Colorado, United States, 80401
Actively Recruiting
7
ClinRe
Thornton, Colorado, United States, 80023
Actively Recruiting
8
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
9
HCA Florida JFK
Atlantis, Florida, United States, 33462
Withdrawn
10
Mease Countryside Hospital
Clearwater, Florida, United States, 34695
Actively Recruiting
11
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
12
HCA Largo
Largo, Florida, United States, 33770
Actively Recruiting
13
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
14
Atlanta VA
Atlanta, Georgia, United States, 30033
Actively Recruiting
15
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
16
Emory
Atlanta, Georgia, United States, 30322
Actively Recruiting
17
Archbold Memorial Hospital
Thomasville, Georgia, United States, 31792
Actively Recruiting
18
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
Actively Recruiting
19
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
20
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States, 67226
Actively Recruiting
21
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
22
Johns Hopkins
Baltimore, Maryland, United States, 21287
Withdrawn
23
Beth Israel Deaconess
Boston, Massachusetts, United States, 02114
Actively Recruiting
24
Mass General
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
Brigham & Women's
Boston, Massachusetts, United States, 02115
Actively Recruiting
26
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Actively Recruiting
27
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
28
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
29
Englewood Health
Englewood, New Jersey, United States, 07631
Actively Recruiting
30
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
31
NC Heart and Vascular
Raleigh, North Carolina, United States, 27607
Actively Recruiting
32
The Lindner Research Center at Christ
Cincinnati, Ohio, United States, 45219
Actively Recruiting
33
Penn State Health Hershey & Berks
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
34
UPMC Pinnacle
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
35
Lifespan Rhode Island & Miriam
Providence, Rhode Island, United States, 02903
Actively Recruiting
36
HCA Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
37
Hendrick Health
Abilene, Texas, United States, 79601
Actively Recruiting
38
Baylor Scott and White - Dallas
Dallas, Texas, United States, 75246
Actively Recruiting
39
Medical City of Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
40
Baylor Scott and White Plano
Plano, Texas, United States, 75093
Actively Recruiting
41
Baylor Scott and White - Temple
Temple, Texas, United States, 76508
Actively Recruiting
42
HCA Chippenham
Richmond, Virginia, United States, 23225
Actively Recruiting
43
Advocate Aurora St. Luke's
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
Research Team
R
Rebecca Apruzzese
CONTACT
S
Susanne Meis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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