Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

Phase 4

Terminated

• Conditions: Percutaneous Transluminal Coronary Angioplasty
• Interventions: Device: everolimus-eluting cobalt-chromium (Xience) stent; Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold

• Registration Number: NCT02831205
• Lead Sponsor: Duk-Woo Park, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-13
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XIENCE EES	everolimus-eluting cobalt-chromium (Xience) stent	-
ABSORB BVS	everolimus-eluting bioresorbable vascular (Absorb) scaffold	-

Primary Outcome Measures

Name	Time	Method
Target lesion failure	1 year	event rate for composite of cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Cardiac death	5 years
Target-vessel myocardial infarction	5 years
Ischemia-driven target-lesion revascularization	5 years
All-cause mortality	5 years
event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction	5 years
Any revascularization	5 years	Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of