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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05946629
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 960 participants
Conditions and interventions
Conditions
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 20, 2023 (Actual)
- Primary completion
- Sep 2027 (Estimated)
- Completion
- Sep 2031 (Estimated)
- Last update posted
- Sep 24, 2026
2023 – 2031
United States locations
- U.S. sites
- 65
- U.S. states
- 32
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Bernards | Jonesboro | Arkansas | 72401 | — |
| CISD Sharp Chula Vista | Chula Vista | California | 91911 | — |
| Cedars Sinai | Los Angeles | California | 90048 | — |
| HCA Los Robles | Thousand Oaks | California | 91360 | — |
| Harbor UCLA | Torrance | California | 90502 | — |
| Colorado Heart and Vascular | Golden | Colorado | 80401 | — |
| ClinRe | Thornton | Colorado | 80023 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Manatee Memorial | Bradenton | Florida | 34208 | — |
| Mease Countryside Hospital | Clearwater | Florida | 34695 | — |
| University of Florida, Jacksonville | Jacksonville | Florida | 32209 | — |
| HCA Largo | Largo | Florida | 33770 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| HCA Northside | St. Petersburg | Florida | 33709 | — |
| HCA Trinity | Trinity | Florida | 34655 | — |
| Atlanta VA | Atlanta | Georgia | 30033 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| Emory | Atlanta | Georgia | 30322 | — |
| Hamilton Medical Center | Dalton | Georgia | 30720 | — |
| Archbold Memorial Hospital | Thomasville | Georgia | 31792 | — |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | — |
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| University of Iowa Medical Center | Iowa City | Iowa | 52242 | — |
| Cardiovascular Research Institute of Kansas | Wichita | Kansas | 67226 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Beth Israel Deaconess | Boston | Massachusetts | 02114 | — |
| Mass General | Boston | Massachusetts | 02114 | — |
| Brigham & Women's | Boston | Massachusetts | 02115 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| HCA Overland Park | Overland Park | Missouri | 66211 | — |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | — |
| University of Nebraska | Omaha | Nebraska | 68198 | — |
| Englewood Health | Englewood | New Jersey | 07631 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Northwell Health Lenox Hill | New York | New York | 10075 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| NC Heart and Vascular | Raleigh | North Carolina | 27607 | — |
| The Lindner Research Center at Christ | Cincinnati | Ohio | 45219 | — |
| UH Cleveland | Cleveland | Ohio | 44120 | — |
| Oklahoma Heart | Oklahoma City | Oklahoma | 73120 | — |
| Penn State Health Hershey & Berks | Hershey | Pennsylvania | 17033 | — |
| UPMC Pinnacle | Mechanicsburg | Pennsylvania | 17050 | — |
| WellSpan York Hospital | York | Pennsylvania | 17403 | — |
| Lifespan Rhode Island & Miriam | Providence | Rhode Island | 02903 | — |
| CHI Memorial | Chattanooga | Tennessee | 37404 | — |
| University of Nebraska | Chattanooga | Tennessee | 37404 | — |
| HCA Centennial | Nashville | Tennessee | 37203 | — |
| Hendrick Health | Abilene | Texas | 79601 | — |
| Texas Health | Dallas | Texas | 75231 | — |
| Baylor Scott and White - Dallas | Dallas | Texas | 75246 | — |
| Medical City of Fort Worth | Fort Worth | Texas | 76104 | — |
| Baylor Scott and White Plano | Plano | Texas | 75093 | — |
| Baylor Scott and White - Temple | Temple | Texas | 76508 | — |
| Intermountain Health - Salt Lake City | Murray | Utah | 84107 | — |
| HCA Chippenham | Richmond | Virginia | 23225 | — |
| CAMC | Charleston | West Virginia | 25304 | — |
| Advocate Aurora St. Luke's | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
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 24, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05946629 live on ClinicalTrials.gov.