Status:
UNKNOWN
Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis
Lead Sponsor:
Odense University Hospital
Conditions:
Coronary Artery Disease
Stable Angina
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 implantat...
Detailed Description
Introduction: Ischemic heart disease (IHD) is characterized by progressive atherosclerosis in coronary arteries and may cause coronary artery stenosis or acute thrombus and occlusion. IHD is often tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04666584
Start Date
December 14 2020
End Date
December 31 2024
Last Update
September 13 2023
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000