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ACTIVE NOT RECRUITING

NCT04859985

The SELUTION DeNovo Study

Sponsor: M.A. Med Alliance S.A.

View on ClinicalTrials.gov

Summary

A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.

Official title: Selution DeNovo - A Prospective Randomized, Multi-centre, International, Open Label, Clinical Trial Comparing the Selution DEB Strategy Versus DES Strategy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3326

Start Date

2021-05-15

Completion Date

2030-10-31

Last Updated

2026-01-22

Healthy Volunteers

Conditions

Coronary Artery Disease

Interventions

DEVICE

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).

DEVICE

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.

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 Exclusion Criteria: 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) * Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion * RVD of trial target lesion \> 5mm * 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

Locations (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, 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