HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging versus Quantative Coronary Angiography guidance
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0002921
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 800
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.
1Angiographic exclusion criteria: any of the followings
1)Small vessel: mean reference size < 2.5 mm by quantitative coronary angiography
2)True bifurcation lesion with a large side branch (reference vessel diameter > 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.
2ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset)
3Prior 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.
4Left ventricular ejection fraction (LVEF) < 30%
5Hypersensitivity 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.
6Persistent thrombocytopenia (platelet count <100,000/µl)
7Any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack or ischemic stroke within the past 6 months
8A known intolerance to a study drug (aspirin, clopidogrel or ticagrelor)
9Patients requiring long-term oral anticoagulants or cilostazol
10Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate(ADP) antagonist is planned within 12 months after the procedure.
11A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
12Any 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.
13Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times upper limit of normal).
14Life expectancy < 5 years for any non-cardiac or cardiac causes
15Unwillingness or inability to comply with the procedures described in this protocol.
16pregnant or breast-feeding or child-bearing potential.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target lesion failure
- Secondary Outcome Measures
Name Time Method 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