Percutaneous Transluminal Coronary Angioplasty
Conditions
Keywords
bioresorbable vascular scaffold, coronary artery disease
Brief summary
The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.
Interventions
DEVICEeverolimus-eluting bioresorbable vascular (Absorb) scaffold
DEVICEeverolimus-eluting cobalt-chromium (Xience) stent
Sponsors
CardioVascular Research Foundation, Korea
Duk-Woo Park, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and more * Diffuse long native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment * Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI * 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
* Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated * Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication * An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure * STEMI requiring primary percutaneous coronary intervention * Cardiogenic shock * Restenotic lesions * Left main * Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion * Heavy calcification proximal to or within the target lesion * Compromised left ventricular dysfunction (LVEF \<30%) * At the time of screening, the subject has a malignancy that is not in remission * Terminal illness with life expectancy \<1 year * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period * Patient's pregnant or breast-feeding or child-bearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 1 year | event rate for composite of cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 5 years | — |
| Target-vessel myocardial infarction | 5 years | — |
| Ischemia-driven target-lesion revascularization | 5 years | — |
| event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction | 5 years | — |
| All-cause mortality | 5 years | — |
| Target-vessel failure | 5 years | death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization |
| Stent thrombosis | 5 years | — |
| event rate of device success or procedural success | 5 years | Device success defined as angiographic evidence of \<30% final residual stenosis of the target lesion. Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death. |
| Patient-reported angina status measured by Seattle angina questionnaire | 5 years | — |
| Any revascularization | 5 years | Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven |
Countries
South Korea
Outcome results
None listed