NCT02796157

Brief Summary

PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
950

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

June 7, 2016

Last Update Submit

May 17, 2018

Conditions

Coronary Artery Disease

Keywords

bioresorbable vascular scaffold, drug eluting stent, coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of composite of major adverse cardiovascular events

    Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)

    1 year after PCI

Study Arms (2)

absorb arm

ACTIVE COMPARATOR

PCI with Absorb everolimus-eluting bioresorbable vascular scaffold

Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold

Xience arm

EXPERIMENTAL

PCI with Xience everolimus-eluting metallic stent

Device: PCI with Xience everolimus-eluting metallic stent

Interventions

PCI with Absorb everolimus-eluting bioresorbable vascular scaffoldDEVICE

Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.

absorb arm
PCI with Xience everolimus-eluting metallic stentDEVICE

Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.

Xience arm

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19-85 years
  • Patients with ischemic heart disease requiring PCI
  • Significant coronary de novo lesion (stenosis \>50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
  • Reference vessel diameter of 2.5 to 3.75 mm by operator assessment

You may not qualify if:

  • Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
  • Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
  • Contraindication or hypersensitivity to anti-platelet agents or contrast media
  • Treated with any metallic stent or BVS within 3 months at other vessel
  • Cardiogenic shock
  • Left ventricular ejection fraction \<40%
  • Pregnant women or women with potential childbearing
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Inability to understand or read the informed content

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

  • Seo J, Ahn JM, Hong SJ, Kang DY, Hong SJ, Her AY, Kim YH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Park DW, Hong MK. Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings. Am J Cardiol. 2020 Jun 1;125(11):1624-1630. doi: 10.1016/j.amjcard.2020.02.031. Epub 2020 Mar 15.

    PMID: 32279841DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 10, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

KR(1)