UnknownNot Applicable

Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis

Denmark82 participantsStarted 2020-12-14

Plain-language summary

The aim of the study is to investigate if lesion preparation with a ScoreFlex balloon compared to a standard non-compliant balloon improve vascular healing and minimize lumen reduction after implantation of a Magmaris bioresorbable scaffold.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with stable angina pectoris and non-ST elevation myocardial infarction referred for invasive coronary angiography and percutaneous coronary intervention at Department of Cardiology, Odense University Hospital (Odense, Denmark) Exclusion Criteria: * participation in other randomized clinical trials * life expectancy \< 1 year * allergy to aspirin, clopidogrel, ticagrelor or prasugrel * eGFR \< 30 mL/min * tortuous and angiographically estimated extremely calcified lesions * ostial, left main and bifurcation lesions * lesions in a reference vessel diameter \< 2.0 mm * hemodynamic instability * scheduled for coronary artery bypass grafting

What they're measuring

Minimal Lumen Area

Timeframe: 6 months after index percutaneous coronary intervention

Trial details

NCT IDNCT04666584

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-08

View on ClinicalTrials.gov More Coronary Artery Disease trials