Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation (ACTIV-BVS)

September 5, 2018 updated by: Young-Hak Kim, MD, PhD
The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
    • Songpa-Gu
      • Seoul, Songpa-Gu, Korea, Republic of
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20 years or older
  • Patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia
  • Willing and able to provide informed written consent
  • Eligible for PCI

Exclusion Criteria:

  • Patients presenting with STEMI within 2 weeks
  • Bypass graft lesion
  • Lesion with left main disease
  • Expected length of scaffold > 40 mm
  • Bifurcation lesion requiring side branch stenting
  • Small vessels < 2.75 mm
  • Stented lesion
  • Suspected coronary spasm even after sufficient nitrate injected
  • Cases in which the IVUS or OCT imaging catheter failed to cross the lesion
  • Poor quality IVUS or OCT images
  • Contraindication to dual anti-platelet therapy
  • Chronic total occlusion
  • Angiographically large-sized vessel (>3.5mm of reference lumen diameter)
  • Life expectancy shorter than 2 years
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optical coherent tomography
Optical coherent tomography provides more detailed information about the morphology of scaffolds, microstructures and coronary vasculature based on tissue characteristics as compared to conventional IVUS. In spite of angiographic success in BVS placement, further scaffold optimization was required in over a quarter of cases based on OCT findings due to malapposition or scaffold under expansion.
Other: Optical coherent tomography
comparative method for BVS
Active Comparator: IntraVascular UltraSound
Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.
Other: IntraVascular UltraSound
The method of goldstandard for decision stent choice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
OCT-measured in-scaffold minimal lumen area
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
OCT-measured minimal scaffold area (MSA)
Time Frame: 1 year
1 year
OCT-measured mean scaffold expansion
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Young-Hak Kim, MD, PhD

Collaborators

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2017

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2016-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not a publicly funded trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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