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

Percutaneous Transluminal Coronary Angioplasty Clinical Trial

— ABSORB-LONG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02831205
• Other study ID #: AMCCV2016-14
• Status: Terminated
• Phase: Phase 4
• First received: July 6, 2016
• Last updated: December 14, 2017
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 800
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Transluminal Coronary Angioplasty

Intervention

Device:
• everolimus-eluting bioresorbable vascular (Absorb) scaffold

• everolimus-eluting cobalt-chromium (Xience) stent

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Duk-Woo Park, MD	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization	1 year
Secondary	Cardiac death		5 years
Secondary	Target-vessel myocardial infarction		5 years
Secondary	Ischemia-driven target-lesion revascularization		5 years
Secondary	All-cause mortality		5 years
Secondary	event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction		5 years
Secondary	Any revascularization	Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven	5 years
Secondary	Target-vessel failure	death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization	5 years
Secondary	Stent thrombosis		5 years
Secondary	event rate of device success or procedural success	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.	5 years
Secondary	Patient-reported angina status measured by Seattle angina questionnaire		5 years