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

NCT02831205 | Terminated Phase 4 DMC

• 1 other identifier: AMCCV2016-14
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Transluminal Coronary Angioplasty

Keywords

bioresorbable vascular scaffold; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Target lesion failure

  event rate for composite of cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-lesion revascularization

  1 year

Secondary Outcomes (10)

• 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

Study Arms (2)

ABSORB BVS

EXPERIMENTAL

Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold

XIENCE EES

ACTIVE COMPARATOR

Device: everolimus-eluting cobalt-chromium (Xience) stent

Interventions

everolimus-eluting bioresorbable vascular (Absorb) scaffold DEVICE

Also known as: ABSORB BVS

ABSORB BVS

everolimus-eluting cobalt-chromium (Xience) stent DEVICE

Also known as: XIENCE EES

XIENCE EES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duk-Woo Park, MD: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 13, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)