Clinical trial NCT02831205: Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
Official title: Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Percutaneous Transluminal Coronary Angioplasty
Keywords: bioresorbable vascular scaffold
coronary artery disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-07-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Target lesion failure
timeFrame: 1 year
Secondary outcomes:
measure: Cardiac death
timeFrame: 5 years
measure: Target-vessel myocardial infarction
timeFrame: 5 years
measure: Ischemia-driven target-lesion revascularization
timeFrame: 5 years
measure: All-cause mortality
timeFrame: 5 years
measure: event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction
timeFrame: 5 years
measure: Any revascularization
timeFrame: 5 years
measure: Target-vessel failure
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: event rate of device success or procedural success
timeFrame: 5 years
measure: Patient-reported angina status measured by Seattle angina questionnaire
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: