Clinical trial NCT04859985: The SELUTION DeNovo Study
Official title: SELUTION DeNovo - A Prospective Randomized, Multi-center, International, Single-blind, Clinical Trial Compared the Selution DEB Strategy Versus DES Strategy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug Eluting Balloon
Coronary
De Novo coronary lesions
Lead sponsor: M.A. Med Alliance S.A.
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 3326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: A Prospective Randomized, Multi-center, International, Single-blind, Clinical trial compared the Selution DEB strategy versus DES strategy.

Detailed description: Randomized, multi-center, international, single-blind, 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 long-term superiority at 5 years of the DEB strategy with TVF as an endpoint All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.

Eligibility criteria: 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

Primary outcomes:
measure: TVF
timeFrame: 1 year after treatment
measure: TVF
timeFrame: 5 years after treatment
Secondary outcomes:
measure: Death or any MI
timeFrame: 30 days after treatment
measure: CD-TVR
timeFrame: 30 days after treatment
measure: TVF
timeFrame: 2, 3, 4, 5 years after treatment
measure: Any revascularization
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Myocardial Infarction (MI)
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Composite of cardiac death or target vessel MI
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: All-cause mortality
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Patient-oriented ARC-2 composite endpoint
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Site-reported stroke
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Site-reported BARC 3-5 Bleeding
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Cost-effectiveness of DEB vs. DES after 12 months in selected countries
timeFrame: 1, 2, 3, 4 and 5 years after treatment
measure: Cost-effectiveness of DEB vs. DES after 12 months in selected countries
timeFrame: 1, 2, 3, 4 and 5 years after treatment
measure: Cost-effectiveness of DEB vs. DES after 12 months in selected countries
timeFrame: 1, 2, 3, 4 and 5 years after treatment
measure: Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Device success
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Lesion success
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
measure: Procedure success
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Academic Teaching Hospital Feldkirch
city: Graz
country: Austria
facility: University Heart Center Graz
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
city: Brno
country: Czechia
facility: University Hospital Brno
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Joensuu
country: Finland
facility: SIUN sote Hospital and Healthcare center
city: La Rochelle
country: France
facility: CH La Rochelle
city: Massy
country: France
facility: Hôpital Jaques Cartier
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Augsburg
country: Germany
facility: Universitätsklinik Augsburg
city: Bad Krozingen
country: Germany
facility: Universitätsklinikum Freiburg
city: Berlin
country: Germany
facility: BG Klinikum Unfallkrankenhaus Berlin
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Bremen
country: Germany
facility: Kardiologisch-Angiologische Praxis • Herzzentrum Bremen
city: Bruchsal
country: Germany
facility: RKH Kliniken Bruchsal Fürst Stirum Klinik
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus
city: Hamburg
country: Germany
facility: Asklepios Kliniken GmbH & Co.
city: Hamburg
country: Germany
facility: University Medical Center Hamburg Eppendorf
city: Koeln
country: Germany
facility: University Koeln
city: Lahr
country: Germany
facility: MEDICLIN Herzzentrum Lahr
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Ulm
country: Germany
facility: Herzklinikum Ulm
city: Alessandria
country: Italy
facility: Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Torino
country: Italy
facility: Ospedale Santa Croce di Moncalieri
city: Vercelli
country: Italy
facility: Ospedale Sant'andrea
city: Amsterdam
country: Netherlands
facility: University Medical Center Amsterdam
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Hilversum
country: Netherlands
facility: Tergooi MC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego UM
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie
city: Rzeszów
country: Poland
facility: Szpital Ministerstwa Spraw Wewnetrznych
city: Singapore
country: Singapore
facility: National Heart Centre Singapore (NHCS)
city: Singapore
country: Singapore
facility: SengKang General Hospital
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro, University Hospital of Vigo
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital of Bern
city: Fribourg
country: Switzerland
facility: Hôpital Cantonal de Fribourg
city: Geneva
country: Switzerland
facility: University Hospital Geneva (HUG)
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: University Zurich
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands, Royal Stoke University Hospital
state: Staffordshire
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch Hospitals
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals
city: Nottingham
country: United Kingdom
facility: Trent Cardiac Centre, Nottingham City Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Sheffield
country: United Kingdom
facility: Northern General, Sheffield
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
Study officials:
References: