A Prospective Randomized, Multi-center, International, Open label, Clinical trial comparing the SELUTION DEB strategy versus DES strategy.

• Conditions: Ischemic heart disease - risk for restenosis; 10011082

• Registration Number: NL-OMON56719
• Lead Sponsor: MedAlliance CardioVascular SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

• 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, patients whose Index procedure is a staged
procedure for non-culprit lesion PCI after Acute Myocardial Infarction (AMI)
may be included in the absence of further documented ischemia/angina.

• Life expectancy >1 year

• Written informed consent by the subject 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified