The SELUTION DeNovo Study

NCT ID: NCT04859985

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2030-10-31

Brief Summary

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

Detailed Description

Randomized, multi-centre, international, open label, clinical trial. Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLR DEB or DES.

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 DEB group (intention to treat analysis).

Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate.

Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm).

The study will test:

1. for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months.

2. for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 5 years. If non-inferiority is then established, superiority of the DEB strategy with TVF as an endpoint will be tested.

All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SELUTION SLR DEB

Device: 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.

Group Type: EXPERIMENTAL

SELUTION SLR

Intervention Type: DEVICE

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

Device: 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.

Group Type: OTHER

DES

Intervention Type: DEVICE

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

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.A. Med Alliance S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Napoli, , 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

Countries

Austria; Czechia; Finland; France; Germany; Italy; Netherlands; Poland; Singapore; Spain; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36642225 (View on PubMed)

Other Identifiers

S2021-02

Identifier Type: -

Identifier Source: org_study_id