The SELUTION DeNovo Study

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: SELUTION SLR; Device: DES

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.

• Study Type: Interventional
• Enrollment (Actual): 3326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria
    • Academic Teaching Hospital Feldkirch
  • Graz, Austria
    • University Heart Center Graz
  • Linz, Austria
    • Kepler Universitätsklinikum GmbH
• Czechia
  • Brno, Czechia
    • University Hospital Brno
  • Ostrava, Czechia
    • University Hospital Ostrava
• Finland
  • Joensuu, Finland
    • SIUN sote Hospital and Healthcare center
• France
  • La Rochelle, France
    • CH La Rochelle
  • Massy, France
    • Hôpital Jaques Cartier
  • Nîmes, France
    • CHU de Nîmes
  • Paris, France
    • Hôpital Europeen Georges Pompidou
  • Pau, France
    • Centre Hospitalier De Pau
  • Rouen, France
    • Clinique Saint Hilaire
• Germany
  • Augsburg, Germany
    • Universitätsklinik Augsburg
  • Bad Krozingen, Germany
    • Universitätsklinikum Freiburg
  • Berlin, Germany
    • Charite Campus Virchow Klinikum
  • Berlin, Germany
    • BG Klinikum Unfallkrankenhaus Berlin
  • Bremen, Germany
    • Kardiologisch-Angiologische Praxis • Herzzentrum Bremen
  • Bruchsal, Germany
    • RKH Kliniken Bruchsal Fürst Stirum Klinik
  • Cologne, Germany
    • University Koeln
  • Dresden, Germany
    • Herzzentrum Dresden GmbH Universitätsklinik
  • Essen, Germany
    • Elisabeth-Krankenhaus
  • Hamburg, Germany
    • Asklepios Kliniken GmbH & Co.
  • Hamburg, Germany
    • University Medical Center Hamburg Eppendorf
  • Lahr, Germany
    • MediClin Herzzentrum Lahr
  • Minden, Germany
    • Johannes Wesling Klinikum Minden
  • Ulm, Germany
    • Herzklinikum Ulm
• Italy
  • Alessandria, Italy
    • Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo
  • Napoli, Italy
    • Clinica Mediterranea
  • Torino, Italy
    • Ospedale Santa Croce di Moncalieri
  • Vercelli, Italy
    • Ospedale Sant'Andrea
• Netherlands
  • Amsterdam, Netherlands
    • University Medical Center Amsterdam
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Hilversum, Netherlands
    • Tergooi Mc
  • Utrecht, Netherlands
    • UMC Utrecht
• Poland
  • Poznan, Poland
    • Szpital Kliniczny Przemienienia Pańskiego UM
  • Rzeszów, Poland
    • Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie
  • Rzeszów, Poland
    • Szpital Ministerstwa Spraw Wewnetrznych
• Singapore
  • Singapore, Singapore
    • Sengkang General Hospital
  • Singapore, Singapore
    • National Heart Centre Singapore (NHCS)
• Spain
  • Barcelona, Spain
    • Hospital Clínico de Barcelona
  • Madrid, Spain
    • Hospital Universitario de La Princesa
  • Vigo, Spain
    • Hospital Alvaro Cunqueiro, University Hospital of Vigo
• Switzerland
  • Basel, Switzerland
    • University Hospital Basel
  • Bern, Switzerland
    • University Hospital of Bern
  • Fribourg, Switzerland
    • Hôpital Cantonal de Fribourg
  • Geneva, Switzerland
    • University Hospital Geneva (HUG)
  • Sankt Gallen, Switzerland
    • HOCH Health Ostschweiz Kantonsspital St.Gallen
  • Zurich, Switzerland
    • University Zurich
• United Kingdom
  • Bournemouth, United Kingdom
    • The Royal Bournemouth and Christchurch Hospitals
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • Bristol, United Kingdom
    • University Hospitals Bristol
  • Edinburgh, United Kingdom
    • Royal Infirmary of Edinburgh
  • Glasgow, United Kingdom
    • Golden Jubilee National Hospital
  • Leicester, United Kingdom
    • Glenfield Hospital
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust
  • Norwich, United Kingdom
    • Norfolk and Norwich University Hospitals
  • Nottingham, United Kingdom
    • Trent Cardiac Centre, Nottingham City Hospital
  • Reading, United Kingdom
    • Royal Berkshire Hospital
  • Sheffield, United Kingdom
    • Northern General, Sheffield
  • Southampton, United Kingdom
    • University Hospital Southampton
  • Worcester, United Kingdom
    • Worcestershire Royal Hospital
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • University Hospitals of North Midlands, Royal Stoke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death or any MI	Cardiac death, non-cardiac death, or any Myocardial Infarction	30 days after treatment
CD-TVR	Clinically driven - Target Vessel Revascularization	30 days after treatment
TVF	Target Vessel Failure	2, 3, 4, 5 years after treatment
Any revascularization	Target lesion revascularization (TLR) - any and clinically driven; Target vessel revascularization (TVR) - any and clinically driven; A new lesion revascularization in a target vessel; Non-Target vessel revascularization	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Myocardial Infarction (MI)	Peri-procedural MI; Target-vessel MI; Non-target-vessel MI; MI type (1 to 5) according to the 4th universal definition	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Composite of cardiac death or target vessel MI	Composite of cardiac death or target vessel Myocardial Infarction	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
All-cause mortality	Cardiac mortality; Non-cardiac mortality	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Patient-oriented ARC-2 composite endpoint	All-cause mortality; Any stroke; Any MI (includes non-target vessel territory); Any revascularization	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Site-reported stroke	Site-reported stroke	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Site-reported BARC 3-5 Bleeding	Site-reported BARC (Bleeding Academic Research Consortium ) 3-5 Bleeding	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries	Total costs of materials used during treatment	1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries	Time of procedure. Total minutes from patient introducer introduction until removal	1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries	Total hospitalization days per procedure.	1, 2, 3, 4 and 5 years after treatment
Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding	Net clinical benefit, a combination of freedom from (Target Vessel Failure) TVF and/or BARC 3-5 bleeding	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Device success	Device success defined as achievement of a final residual diameter stenosis of < 30% (site-reported), using the assigned device only	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Lesion success	Lesion success defined as achievement of < 30% residual stenosis (site-reported), using any PCI method	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Procedure success	Procedure success defined as achievement of a final diameter stenosis of < 30% (site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment

Collaborators and Investigators

• Sponsor: M.A. Med Alliance S.A.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): September 15, 2025
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Coronary; Drug Eluting Balloon; De Novo coronary lesions
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: S2021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No