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Clinical Trials in the UK / NCT04859985
Active, not recruiting Not applicable

The SELUTION DeNovo Study

NCT04859985 · tracked via the Priya Life Science UK tracker
Sponsor
M.A. Med Alliance S.A.
Phase
Not applicable
Started
2021-05-15
Last updated
2026-01-22

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

SELUTION SLRDES

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
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

+ 22 more sites — see the full list on the official registry below.

More M.A. Med Alliance S.A. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04859985 on ClinicalTrials.gov ↗ ← All trials in the UK