SELUTION 4 De Novo Small Vessel IDE Trial
Public ClinicalTrials.gov record NCT05946629. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT05946629
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- M.A. Med Alliance S.A.
- Industry
- Enrollment
- 960 participants
Conditions and interventions
Conditions
Interventions
- PCI with FDA approved "-limus" DES Device
- PCI with SELUTION SLR DCB Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 19, 2023
- Primary completion
- May 31, 2027
- Completion
- May 31, 2031
- Last update posted
- Sep 28, 2025
2023 – 2031
United States locations
- U.S. sites
- 43
- U.S. states
- 22
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Bernards | Jonesboro | Arkansas | 72401 | Recruiting |
| CISD Sharp Chula Vista | Chula Vista | California | 91911 | Recruiting |
| Cedars Sinai | Los Angeles | California | 90048 | Recruiting |
| HCA Los Robles | Thousand Oaks | California | 91360 | Recruiting |
| Harbor UCLA | Torrance | California | 90502 | Recruiting |
| Colorado Heart and Vascular | Golden | Colorado | 80401 | Recruiting |
| ClinRe | Thornton | Colorado | 80023 | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Recruiting |
| HCA Florida JFK | Atlantis | Florida | 33462 | Withdrawn |
| Mease Countryside Hospital | Clearwater | Florida | 34695 | Recruiting |
| University of Florida, Jacksonville | Jacksonville | Florida | 32209 | Recruiting |
| HCA Largo | Largo | Florida | 33770 | Recruiting |
| AdventHealth Orlando | Orlando | Florida | 32803 | Recruiting |
| Atlanta VA | Atlanta | Georgia | 30033 | Recruiting |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | Recruiting |
| Emory | Atlanta | Georgia | 30322 | Recruiting |
| Archbold Memorial Hospital | Thomasville | Georgia | 31792 | Recruiting |
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | Recruiting |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | Recruiting |
| Cardiovascular Research Institute of Kansas | Wichita | Kansas | 67226 | Recruiting |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | Recruiting |
| Johns Hopkins | Baltimore | Maryland | 21287 | Withdrawn |
| Beth Israel Deaconess | Boston | Massachusetts | 02114 | Recruiting |
| Mass General | Boston | Massachusetts | 02114 | Recruiting |
| Brigham & Women's | Boston | Massachusetts | 02115 | Recruiting |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | Recruiting |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | Recruiting |
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | Recruiting |
| Englewood Health | Englewood | New Jersey | 07631 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| NC Heart and Vascular | Raleigh | North Carolina | 27607 | Recruiting |
| The Lindner Research Center at Christ | Cincinnati | Ohio | 45219 | Recruiting |
| Penn State Health Hershey & Berks | Hershey | Pennsylvania | 17033 | Recruiting |
| UPMC Pinnacle | Mechanicsburg | Pennsylvania | 17050 | Recruiting |
| Lifespan Rhode Island & Miriam | Providence | Rhode Island | 02903 | Recruiting |
| HCA Centennial | Nashville | Tennessee | 37203 | Recruiting |
| Hendrick Health | Abilene | Texas | 79601 | Recruiting |
| Baylor Scott and White - Dallas | Dallas | Texas | 75246 | Recruiting |
| Medical City of Fort Worth | Fort Worth | Texas | 76104 | Recruiting |
| Baylor Scott and White Plano | Plano | Texas | 75093 | Recruiting |
| Baylor Scott and White - Temple | Temple | Texas | 76508 | Recruiting |
| HCA Chippenham | Richmond | Virginia | 23225 | Recruiting |
| Advocate Aurora St. Luke's | Milwaukee | Wisconsin | 53215 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05946629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2025 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05946629 live on ClinicalTrials.gov.