SELUTION SLR: Patients randomized to the SELUTION SLR™ DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis \> 30% or FFR \< 0.8) before or after use of DEB will receive a DES but remain in the SELUTION SLR™ DEB group (intention to treat analysis).
DES: For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
| Facility | City | Region | Status |
|---|---|---|---|
| Academic Teaching Hospital Feldkirch | Feldkirch | Austria | |
| University Heart Center Graz | Graz | Austria | |
| Kepler Universitätsklinikum GmbH | Linz | Austria | |
| University Hospital Brno | Brno | Czechia | |
| University Hospital Ostrava | Ostrava | Czechia | |
| SIUN sote Hospital and Healthcare center | Joensuu | Finland | |
| CH La Rochelle | La Rochelle | France | |
| Hôpital Jaques Cartier | Massy | France | |
| CHU de Nîmes | Nîmes | France | |
| Hôpital Européen Georges Pompidou | Paris | France | |
| Centre Hospitalier de Pau | Pau | France | |
| Clinique Saint Hilaire | Rouen | France | |
| Universitätsklinik Augsburg | Augsburg | Germany | |
| Universitätsklinikum Freiburg | Bad Krozingen | Germany | |
| BG Klinikum Unfallkrankenhaus Berlin | Berlin | Germany | |
| Charite Campus Virchow Klinikum | Berlin | Germany | |
| Kardiologisch-Angiologische Praxis • Herzzentrum Bremen | Bremen | Germany | |
| RKH Kliniken Bruchsal Fürst Stirum Klinik | Bruchsal | Germany | |
| University Koeln | Cologne | Germany | |
| Herzzentrum Dresden GmbH Universitätsklinik | Dresden | Germany | |
| Elisabeth-Krankenhaus | Essen | Germany | |
| Asklepios Kliniken GmbH & Co. | Hamburg | Germany | |
| University Medical Center Hamburg Eppendorf | Hamburg | Germany | |
| MEDICLIN Herzzentrum Lahr | Lahr | Germany | |
| Johannes Wesling Klinikum Minden | Minden | Germany | |
| Herzklinikum Ulm | Ulm | Germany | |
| Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | |
| Clinica Mediterranea | Naples | Italy | |
| Ospedale Santa Croce di Moncalieri | Torino | Italy | |
| Ospedale Sant'andrea | Vercelli | Italy | |
| University Medical Center Amsterdam | Amsterdam | Netherlands | |
| University Medical Center Groningen | Groningen | Netherlands | |
| Tergooi MC | Hilversum | Netherlands | |
| UMC Utrecht | Utrecht | Netherlands | |
| Szpital Kliniczny Przemienienia Pańskiego UM | Poznan | Poland | |
| Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie | Rzeszów | Poland | |
| Szpital Ministerstwa Spraw Wewnetrznych | Rzeszów | Poland | |
| National Heart Centre Singapore (NHCS) | Singapore | Singapore | |
| SengKang General Hospital | Singapore | Singapore | |
| Hospital Clinico de Barcelona | Barcelona | Spain |
+ 22 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04859985 on ClinicalTrials.gov ↗ ← All trials in the UK