5 active not recruiting, 2 completed, 1 recruiting, 1 unknown. 8 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 8 | Active not recruiting 5, Completed 1, Recruiting 1, Unknown 1 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| SELUTION 4 De Novo Small Vessel IDE Trial PCI with SELUTION SLR DCB, PCI with FDA approved "-limus" DES - Coronary Artery Disease | Not applicable | Active not recruiting | M.A. Med Alliance S.A. | 960 | 2023-10-20 | 2026-09-24 |
| SELUTION4SFA Trial SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA) - Peripheral Arterial Disease, Superficial Femoral Artery Stenosis | Not applicable | Active not recruiting | M.A. Med Alliance S.A. | 300 | 2022-12-01 | 2026-01-12 |
| Selution Sirolimus-eluting Balloon for Internal Pudendal-penile Artery Disease-related Erectile Dysfunction Selution SLR™ sirolimus-eluting balloon, Plain old balloon angioplasty - Erectile Dysfunction, Peripheral Arterial Disease | Not applicable | Unknown | National Taiwan University Hospital | 54 | 2022-09-19 | 2024-04-30 |
| SELUTION4BTK Trial SELUTION SLR™ DEB 014, Plain (Uncoated) Balloon Angioplasty (PTA) - Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities | Not applicable | Recruiting | M.A. Med Alliance S.A. | 376 | 2022-05-19 | 2026-04-28 |
| The SELUTION DeNovo Study SELUTION SLR, DES - Coronary Artery Disease | Not applicable | Active not recruiting | M.A. Med Alliance S.A. | 3326 | 2021-05-15 | 2026-01-22 |
| SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB) - Peripheral Artery Disease | Not applicable | Active not recruiting | M.A. Med Alliance S.A. | 723 | 2021-02-08 | 2025-09-23 |
| SELUTION SLR™ 014 In-stent Restenosis SELUTION SLR 014 DEB, Standard of Care - Coronary Restenosis | Not applicable | Active not recruiting | M.A. Med Alliance S.A. | 418 | 2020-07-06 | 2026-10-20 |
| SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications SELUTION SLR™ DEB, Control Arm - AV Fistula | Not applicable | Completed | M.A. Med Alliance S.A. | 84 | 2020-04-10 | 2025-08-29 |
| First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries SELUTION DCB (sirolimus coated balloon) - Patients With Peripheral Artery Disease in the SFA or PA | Phase 1 | Completed | M.A. Med Alliance S.A. | 50 | 2016-10-01 | 2019-11-20 |
Peripheral Arterial Disease (4) · Coronary Artery Disease (2) · Angina, Stable (1) · Arteriovenous Fistula (1) · Coronary Restenosis (1) · Erectile Dysfunction (1) · Non-ST Elevated Myocardial Infarction (1)
Angioplasty, Balloon (2) · Percutaneous Coronary Intervention (1)
Germany (6) · Netherlands (4) · Singapore (4) · United States (4) · Austria (3) · France (3) · Italy (3) · Switzerland (3) · Belgium (2) · Greece (2) · Hong Kong (2) · United Kingdom (2) · Argentina (1) · Brazil (1) · Canada (1)
Donald E Cutlip, MD (1) · Ron Waksman, MD (1) · Thomas Zeller, Prof Dr Med (1) · Tzung-Dau Wang, MD, PhD (1)
PMID 24832642, PMID 27629440, PMID 30343618, PMID 32666871, PMID 33314715, PMID 36642225, PMID 39952378, PMID 41984017, PMID 42290366