3,326
Participants
Start Date
May 15, 2021
Primary Completion Date
September 15, 2025
Study Completion Date
October 31, 2030
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.
Academic Teaching Hospital Feldkirch, Feldkirch
University Heart Center Graz, Graz
Kepler Universitätsklinikum GmbH, Linz
University Hospital Brno, Brno
University Hospital Ostrava, Ostrava
SIUN sote Hospital and Healthcare center, Joensuu
CH La Rochelle, La Rochelle
Hôpital Jaques Cartier, Massy
CHU de Nîmes, Nîmes
Hôpital Européen Georges Pompidou, Paris
Centre Hospitalier de Pau, Pau
Clinique Saint Hilaire, Rouen
Universitätsklinik Augsburg, Augsburg
Universitätsklinikum Freiburg, Bad Krozingen
BG Klinikum Unfallkrankenhaus Berlin, Berlin
Charite Campus Virchow Klinikum, Berlin
Kardiologisch-Angiologische Praxis • Herzzentrum Bremen, Bremen
RKH Kliniken Bruchsal Fürst Stirum Klinik, Bruchsal
University Koeln, Cologne
Herzzentrum Dresden GmbH Universitätsklinik, Dresden
Elisabeth-Krankenhaus, Essen
Asklepios Kliniken GmbH & Co., Hamburg
University Medical Center Hamburg Eppendorf, Hamburg
MEDICLIN Herzzentrum Lahr, Lahr
Johannes Wesling Klinikum Minden, Minden
Herzklinikum Ulm, Ulm
Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo, Alessandria
Clinica Mediterranea, Napoli
Ospedale Santa Croce di Moncalieri, Torino
Ospedale Sant'andrea, Vercelli
University Medical Center Amsterdam, Amsterdam
University Medical Center Groningen, Groningen
Tergooi MC, Hilversum
UMC Utrecht, Utrecht
Szpital Kliniczny Przemienienia Pańskiego UM, Poznan
Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie, Rzeszów
Szpital Ministerstwa Spraw Wewnetrznych, Rzeszów
National Heart Centre Singapore (NHCS), Singapore
SengKang General Hospital, Singapore
Hospital Clinico de Barcelona, Barcelona
Hospital Universitario de La Princesa, Madrid
Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo
University Hospital Geneva (HUG), Geneva
University Hospital Basel, Basel
University Hospital of Bern, Bern
Hôpital Cantonal de Fribourg, Fribourg
HOCH Health Ostschweiz Kantonsspital St.Gallen, Sankt Gallen
University Zurich, Zurich
The Royal Bournemouth and Christchurch Hospitals, Bournemouth
Royal Sussex County Hospital, Brighton
University Hospitals Bristol, Bristol
Royal Infirmary of Edinburgh, Edinburgh
Golden Jubilee National Hospital, Glasgow
Glenfield Hospital, Leicester
Manchester University NHS Foundation Trust, Manchester
Norfolk and Norwich University Hospitals, Norwich
Trent Cardiac Centre, Nottingham City Hospital, Nottingham
Royal Berkshire Hospital, Reading
Northern General, Sheffield, Sheffield
University Hospital Southampton, Southampton
Worcestershire Royal Hospital, Worcester
University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent
M.A. Med Alliance S.A.
INDUSTRY