NCT02831218

Brief Summary

The purpose of this study is to compare clinical outcomes between QCA(quantitative coronary angiography)-guided and imaging-guided strategy in patients with native coronary artery disease undergoing Bioresorbable Vascular Scaffold implantation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

July 6, 2016

Last Update Submit

January 3, 2018

Conditions

Percutaneous Transluminal Coronary Angioplasty

Keywords

bioresorbable vascular scaffoldcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Target lesion failure

    the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.

    1 year

Secondary Outcomes (10)

  • Device success

    1 day

  • Procedural success

    24 hours

  • Death

    1 year and 5 years

  • Myocardial infarction

    1 year and 5 years

  • Scaffold thrombosis

    1 year and 5 years

  • +5 more secondary outcomes

Study Arms (4)

QCA and Aspirin alone

EXPERIMENTAL
Procedure: QCA and Aspirin

QCA and Clopidogrel alone

EXPERIMENTAL
Procedure: QCA and Clopidogrel

Imaging guided and Aspirin alone

ACTIVE COMPARATOR
Procedure: Imaging guided and Aspirin

Imaging guided and Clopidogrel alone

ACTIVE COMPARATOR
Procedure: Imaging guided and Clopidogrel

Interventions

QCA and AspirinPROCEDURE

QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.

QCA and Aspirin alone
QCA and ClopidogrelPROCEDURE

QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.

QCA and Clopidogrel alone
Imaging guided and AspirinPROCEDURE

BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.

Imaging guided and Aspirin alone
Imaging guided and ClopidogrelPROCEDURE

BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day\[or ticagrelor 90mg po bid\]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.

Imaging guided and Clopidogrel alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women at least 18 years of age
  • Typical chest pain or objective evidence of myocardial ischemia suitable for elective percutaneous coronary intervention
  • Native coronary artery lesions with lesion length ≤ 50mm and reference vessel diameter of 2.3 - 3.75mm by QCA(quantitative coronary angiography) assessment
  • 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:

  • Small vessel: mean reference size \< 2.3 mm by QCA(quantitative coronary angiography)
  • True bifurcation lesion with a large side branch (reference vessel diameter \> 2.3mm) requiring a complex two-stent approach
  • Left main lesions
  • Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending artery, or left circumflex artery
  • Impaired delivery of the Absorb BVS is expected:
  • Extreme angulation (≥90°) proximal to or within the target lesion.
  • Excessive tortuosity (≥two 45° angles) proximal to or within the target lesion.
  • Moderate or heavy calcification proximal to or within the target lesion. 6. In-stent restenotic lesions
  • ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset)
  • Prior percutaneous coronary intervention within the target vessel during the last 12 months.
  • Prior percutaneous coronary intervention within the non-target vessel or any peripheral intervention is acceptable if performed anytime \>30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
  • Left ventricular ejection fraction (LVEF) \< 30%
  • Hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
  • Persistent thrombocytopenia (platelet count \<100,000/µl)
  • Any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack (TIA) or ischemic stroke within the past 6 months
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
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

December 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations

KR(1)