The SELUTION DeNovo Study
Selution DeNovo - A Prospective Randomized, Multi-centre, International, Open Label, Clinical Trial Comparing the Selution DEB Strategy Versus DES Strategy.
1 other identifier
interventional
3,326
12 countries
62
Brief Summary
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started May 2021
Longer than P75 for not_applicable coronary-artery-disease
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedStudy Start
First participant enrolled
May 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2030
ExpectedJanuary 22, 2026
January 1, 2026
4.3 years
March 23, 2021
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
TVF
\- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year
1 year after treatment
TVF
\- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years
5 years after treatment
Secondary Outcomes (17)
Death or any MI
30 days after treatment
CD-TVR
30 days after treatment
TVF
2, 3, 4, 5 years after treatment
Any revascularization
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Myocardial Infarction (MI)
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
- +12 more secondary outcomes
Study Arms (2)
SELUTION SLR DEB
EXPERIMENTALDevice: SELUTION SLR DEB. For patients randomized to the DEB strategy, all target lesions should be treated with DEB after appropriate lesion preparation, but provisional DES implantation is acceptable if the angiographic result is considered insufficient either after lesion preparation of after DEB treatment (poor flow, dissection type C or higher, residual stenosis \> 30%). For bifurcation lesions, when both main and side- branch are considered to require treatment, a DEB should be used for both.
DES
OTHERDevice: Drug Eluting Stent. 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.
Interventions
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).
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.
Eligibility Criteria
You may not qualify if:
- Age \< 18 years (or 21 according to countries legal age)
- Subject is pregnant or breast-feeding
- Definite or suspected clinically active covid-19 infection
- Subject is under judicial protection, tutorship or curatorship (for France only)
- Subject is unable to fully comply with the study protocol
- Contraindications to dual antiplatelet therapy, sirolimus or its analogues
- Presentation with STEMI
- Presentation with NSTEMI and ongoing chest pain or hemodynamic instability
- Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock)
- Chronic NYHA class III or IV heart failure prior to index PCI
- Known LVEF \< 30% 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
- 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)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
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
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Alvaro Cunqueiro, University Hospital of Vigo
Vigo, Spain
University Hospital Basel
Basel, Switzerland
University Hospital of Bern
Bern, Switzerland
Hôpital Cantonal de Fribourg
Fribourg, Switzerland
University Hospital Geneva (HUG)
Geneva, Switzerland
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, Switzerland
University Zurich
Zurich, Switzerland
University Hospitals of North Midlands, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
The Royal Bournemouth and Christchurch Hospitals
Bournemouth, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
University Hospitals Bristol
Bristol, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Norfolk and Norwich University Hospitals
Norwich, United Kingdom
Trent Cardiac Centre, Nottingham City Hospital
Nottingham, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Northern General, Sheffield
Sheffield, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Worcestershire Royal Hospital
Worcester, United Kingdom
Related Publications (1)
Spaulding C, Krackhardt F, Bogaerts K, Urban P, Meis S, Morice MC, Eccleshall S. Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Am Heart J. 2023 Apr;258:77-84. doi: 10.1016/j.ahj.2023.01.007. Epub 2023 Jan 13.
PMID: 36642225DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2021
First Posted
April 26, 2021
Study Start
May 15, 2021
Primary Completion
September 15, 2025
Study Completion (Estimated)
October 31, 2030
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share