Status:
ACTIVE_NOT_RECRUITING
The SELUTION DeNovo Study
Lead Sponsor:
M.A. Med Alliance S.A.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
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) w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2030
Estimated Enrollment :
3326 Patients enrolled
Trial Details
Trial ID
NCT04859985
Start Date
May 15 2021
End Date
October 31 2030
Last Update
December 11 2025
Active Locations (62)
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1
Academic Teaching Hospital Feldkirch
Feldkirch, Austria
2
University Heart Center Graz
Graz, Austria
3
Kepler Universitätsklinikum GmbH
Linz, Austria
4
University Hospital Brno
Brno, Czechia