NCT04859985Active, not recruiting
The SELUTION DeNovo Study
Selution DeNovo - A Prospective Randomized, Multi-centre, International, Open Label, Clinical Trial Comparing the Selution DEB Strategy Versus DES Strategy.
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 3326 (actual)
- First submitted
- 23 Mar 2021
- Start date
- 15 May 2021
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- M.A. Med Alliance S.A.
- Diseases
- Coronary artery disease
- NCT number
- NCT04859985
What you commit to
- Study type: Interventional
- Participants enrolled: 3326
- From 15 May 2021 to the primary completion date, 15 Sept 2025
- 62 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to dual antiplatelet therapy, sirolimus or its analogues
- Chronic NYHA class III or IV heart failure prior to index PCI
- Previous PCI of a trial target vessel at any time
- Previous PCI of a non-trial target vessel within 30 days
- Planned major surgery within one month following the procedure
- Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up
Other illness
- Definite or suspected clinically active covid-19 infection
Lab values
- Known LVEF \< 30% prior to index PCI
Age
- Age \< 18 years (or 21 according to countries legal age)
Other
- Subject is pregnant or breast-feeding
- Subject is under judicial protection, tutorship or curatorship (for France only)
- Subject is unable to fully comply with the study protocol
- Presentation with STEMI
- Presentation with NSTEMI and ongoing chest pain or hemodynamic instability
- Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock)
- Trial target lesion located in the left main or any arterial or venous graft
- Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR)
- Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion
- RVD of trial target lesion \> 5mm
Criteria the registry did not label
- Subjects must meet all the following criteria to participate in the trial:
- Subject age is ≥ 18 years (or 21 according to countries legal age)
- Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug.
- Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation.
- Life expectancy \>1 year
- Written informed consent by the subject or her/his legally authorized representative for participation in the study
- One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such.
- The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is \< 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting.
- All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis \>50% and \<100% with distal flow at least TIMI 2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Academic Teaching Hospital Feldkirch Coordinator of this site? Confirm its status | Feldkirch | Austria | Unknown status |
| University Heart Center Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Kepler Universitatsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| University Hospital of Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hôpital Cantonal de Fribourg Coordinator of this site? Confirm its status | Fribourg | Switzerland | Unknown status |
| University Hospital Geneva (HUG) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| HOCH Health Ostschweiz - Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| University Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Universitätsklinik Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| Universitätsklinikum Freiburg Coordinator of this site? Confirm its status | Bad Krozingen | Germany | Unknown status |
| BG Klinikum Unfallkrankenhaus Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Charité Campus Virchow-Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Kardiologisch-Angiologische Praxis - Herzzentrum Bremen Coordinator of this site? Confirm its status | Bremen | Germany | Unknown status |
| RKH Kliniken Bruchsal Fürst Stirum Klinik Coordinator of this site? Confirm its status | Bruchsal | Germany | Unknown status |
| University Koeln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Herzzentrum Dresden GmbH Universitätsklinik Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Elisabeth-Krankenhaus Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Asklepios Kliniken GmbH & Co. Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| MediClin Herzzentrum Lahr Coordinator of this site? Confirm its status | Lahr | Germany | Unknown status |
| Johannes Wesling Klinikum Minden Coordinator of this site? Confirm its status | Minden | Germany | Unknown status |
| Herzklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Hospital Clínico de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Alvaro Cunqueiro-University Hospital of Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| SIUN sote Hospital and Healthcare center Coordinator of this site? Confirm its status | Joensuu | Finland | Unknown status |
| CH La Rochelle Coordinator of this site? Confirm its status | La Rochelle | France | Unknown status |
| Hôpital Jaques Cartier Coordinator of this site? Confirm its status | Massy | France | Unknown status |
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier de Pau Coordinator of this site? Confirm its status | Pau | France | Unknown status |
| Clinique Saint-Hilaire Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| The Royal Bournemouth and Christchurch Hospitals Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| Royal Sussex County Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| University Hospitals Bristol Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Royal Infirmary of Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Golden Jubilee National Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Glenfield Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospitals Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| Trent Cardiac Centre, Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Royal Berkshire Hospital Coordinator of this site? Confirm its status | Reading | United Kingdom | Unknown status |
| Northern General, Sheffield Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| University Hospitals of North Midlands, Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Worcestershire Royal Hospital Coordinator of this site? Confirm its status | Worcester | United Kingdom | Unknown status |
| Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo Coordinator of this site? Confirm its status | Alessandria | Italy | Unknown status |
| Clinica Mediterranea Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale Santa Croce di Moncalieri Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Ospedale Sant'Andrea Coordinator of this site? Confirm its status | Vercelli | Italy | Unknown status |
| University Medical Center Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Tergooi MC Coordinator of this site? Confirm its status | Hilversum | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Szpital Kliniczny Przemienienia Pańskiego UM Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Unknown status |
| Szpital Ministerstwa Spraw Wewnetrznych Coordinator of this site? Confirm its status | Rzeszów | Poland | Unknown status |
| National Heart Centre Singapore (NHCS) Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Sengkang General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.