The SELUTION DeNovo Study
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Eluting Balloon, Coronary, De Novo coronary lesions
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
Sites / Locations
- Academic Teaching Hospital FeldkirchRecruiting
- University Heart Center GrazRecruiting
- University Hospital BrnoRecruiting
- University Hospital OstravaRecruiting
- SIUN sote Hospital and Healthcare centerRecruiting
- CH La RochelleRecruiting
- Hôpital Jaques CartierRecruiting
- CHU de NîmesRecruiting
- Hôpital Européen Georges PompidouRecruiting
- Centre Hospitalier de PauRecruiting
- Clinique Saint HilaireRecruiting
- Universitätsklinik AugsburgRecruiting
- BG Klinikum Unfallkrankenhaus BerlinRecruiting
- Charite Campus Virchow KlinikumRecruiting
- RKH Kliniken Bruchsal Fürst Stirum KlinikRecruiting
- Elisabeth-KrankenhausRecruiting
- Asklepios Kliniken GmbH & Co.Recruiting
- University Medical Center Hamburg EppendorfRecruiting
- University KoelnRecruiting
- MEDICLIN Herzzentrum LahrRecruiting
- Johannes Wesling Klinikum MindenRecruiting
- Universitätsklinikum TübingenRecruiting
- Herzklinikum UlmRecruiting
- Ospedale Civile Santi Antonio e Biagio e Cesare ArrigoRecruiting
- Clinica MediterraneaRecruiting
- Ospedale Santa Croce di MoncalieriRecruiting
- Ospedale Sant'andreaRecruiting
- Szpital Kliniczny Przemienienia Pańskiego UMRecruiting
- Kliniczny Szpital Wojewódzki Nr. 2 w RzeszowieRecruiting
- Szpital Ministerstwa Spraw WewnetrznychRecruiting
- University Hospital of BernRecruiting
- University Hospital Geneva (HUG)Recruiting
- University ZurichRecruiting
- University Hospitals of North Midlands, Royal Stoke University HospitalRecruiting
- The Royal Bournemouth and Christchurch HospitalsRecruiting
- Royal Sussex County HospitalRecruiting
- University Hospitals BristolRecruiting
- Royal Infirmary of EdinburghRecruiting
- Golden Jubilee National HospitalRecruiting
- Glenfield HospitalRecruiting
- Manchester University NHS Foundation TrustRecruiting
- Norfolk and Norwich University HospitalsRecruiting
- Trent Cardiac Centre, Nottingham City HospitalRecruiting
- Royal Berkshire HospitalRecruiting
- Northern General, SheffieldRecruiting
- Worcestershire Royal HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
SELUTION SLR DEB
DES
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: 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.