quantitative coronary angiography versus imaging guidance for bioresorbable vascular scaffold implantation

Conditions: Percutaneous Transluminal Coronary Angioplasty

Summary: the purpose of this study is to compare clinical outcomes between qca(quantitative coronary angiography)-guided and imaging-guided strategy in patients with native coronary artery disease undergoing bioresorbable vascular scaffold implantation.


Eligibility criteria:
inclusion criteria: * men or women at least 18 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 reference vessel diameter of 2.3 - 3.75mm by qca(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: * angiographic exclusion criteria: any of the followings 1. small vessel: mean reference size \< 2.3 mm by qca(quantitative coronary angiography) 2. true bifurcation lesion with a large side branch (reference vessel diameter \> 2.3mm) requiring a complex two-stent approach 3. left main lesions 4. ostial lesions within 3mm of the origin: right coronary artery, left anterior descending artery, or left circumflex artery 5. impaired delivery of the absorb bvs is expected: * extreme angulation (≥90°) proximal to or within the target lesion. * excessive tortuosity (≥two 45° angles) proximal to or within the target lesion. * moderate or heavy calcification proximal to or within the target lesion. 6. in-stent restenotic lesions * st-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset) * 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. * left ventricular ejection fraction (lvef) \< 30% * hypersensitivity or contraindication to device material and its degradants (everolimus, poly (l-lactide), poly (dl-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. * persistent thrombocytopenia (platelet count \<100,000/µl) * any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack (tia) or ischemic stroke within the past 6 months * a known intolerance to a study drug (aspirin, clopidogrel or ticagrelor) * patients requiring long-term oral anticoagulants or cilostazol * any surgery requiring general anesthesia or discontinuation of aspirin and/or an adp antagonist is planned within 12 months after the procedure. * a diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. * any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study. * hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alt or ast \> 3 times upper limit of normal). * life expectancy \< 5 years for any non-cardiac or cardiac causes * unwillingness or inability to comply with the procedures described in this protocol. * patient's pregnant or breast-feeding or child-bearing potential.

Keywords: bioresorbable vascular scaffold coronary artery disease