The SELUTION DeNovo Study

Coronary Artery Disease Clinical Trial

Official title:

SELUTION DeNovo - A Prospective Randomized, Multi-center, International, Single-blind, Clinical Trial Compared the Selution DEB Strategy Versus DES Strategy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859985
• Other study ID #: S2021-02
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: April 1, 2029

Study information

• Verified date: May 2024
• Source: M.A. Med Alliance S.A.
• Contact: Team SelutionDenovo
• Phone: 00 41 22 363 7890
• Email: selutiondenovo[@]medalliance.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3326
• Est. completion date: April 1, 2029
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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).
• 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.

Locations

Country	Name	City	State
Austria	Academic Teaching Hospital Feldkirch	Feldkirch
Austria	University Heart Center Graz	Graz
Austria	Kepler Universitätsklinikum GmbH	Linz
Czechia	University Hospital Brno	Brno
Czechia	University Hospital Ostrava	Ostrava
Finland	SIUN sote Hospital and Healthcare center	Joensuu
France	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
Germany	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	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Elisabeth-Krankenhaus	Essen
Germany	Asklepios Kliniken GmbH & Co.	Hamburg
Germany	University Medical Center Hamburg Eppendorf	Hamburg
Germany	University Koeln	Koeln
Germany	MEDICLIN Herzzentrum Lahr	Lahr
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Herzklinikum Ulm	Ulm
Italy	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
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Tergooi MC	Hilversum
Netherlands	UMC Utrecht	Utrecht
Poland	Szpital Kliniczny Przemienienia Panskiego UM	Poznan
Poland	Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie	Rzeszów
Poland	Szpital Ministerstwa Spraw Wewnetrznych	Rzeszów
Singapore	National Heart Centre Singapore (NHCS)	Singapore
Singapore	SengKang General Hospital	Singapore
Spain	Hospital Clinico de Barcelona	Barcelona
Spain	Hospital Alvaro Cunqueiro, University Hospital of Vigo	Vigo
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital of Bern	Bern
Switzerland	Hôpital Cantonal de Fribourg	Fribourg
Switzerland	University Hospital Geneva (HUG)	Geneva
Switzerland	Kantonsspital St. Gallen	Saint Gallen
Switzerland	University Zurich	Zürich
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	University Hospitals of North Midlands, Royal Stoke University Hospital	Stoke-on-Trent	Staffordshire
United Kingdom	Worcestershire Royal Hospital	Worcester

Sponsors (1)

Lead Sponsor	Collaborator
M.A. Med Alliance S.A.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Death or any MI	Cardiac death, non-cardiac death, or any Myocardial Infarction	30 days after treatment
Secondary	CD-TVR	Clinically driven - Target Vessel Revascularization	30 days after treatment
Secondary	TVF	Target Vessel Failure	2, 3, 4, 5 years after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	All-cause mortality	Cardiac mortality; Non-cardiac mortality	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Secondary	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
Secondary	Site-reported stroke	Site-reported stroke	30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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