None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Imaging guided Bioresorbable scaffold implantation vs Quantitative coronary angiography guided Bioresorbable scaffold implantation
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or women at least 19 years of age Typical chest pain or objective evidence of myocardial ischemia suitable for elective percutaneous coronary intervention Native coronary artery lesions with lesion length 50mm and less and reference vessel diameter of 2.5 ~ 3.75mm by quantitative coronary angiography assessment The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
Exclusion criteria: 1 Angiographic exclusion criteria: any of the followings 1) Small vessel: mean reference size 2.5mm) requiring a complex two-stent approach 3) Left main lesions 4) Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending, or left circumflex artery 5) Impaired delivery of the Absorb bio- resorbable vascular scaffold is expected: a. Extreme angulation (=90°) proximal to or within the target lesion. b. Excessive tortuosity (=two 45° angles) proximal to or within the target lesion. 2 ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset) 3 Prior percutaneous coronary intervention within the target vessel during the last 12 months. Prior percutaneous coronary intervention within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated. 4 Left ventricular ejection fraction (LVEF) 3 times upper limit of normal). 14 Life expectancy < 5 years for any non-cardiac or cardiac causes 15 Unwillingness or inability to comply with the procedures described in this protocol. 16 pregnant or breast-feeding or child-bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success;Procedural success;Myocardial infarction;Scaffold thrombosis;Stroke;Target lesion revascularization;Any revascularization;Target lesion failure (TLR);Composite event of cardiac death, target vessel myocardial infarction, stroke, or clinically significant bleeding;In-scaffold restenosis on coronary CT angiography | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung-jung Park
University of Ulsan
Outcome results
None listed