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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Optical coherent tomography
IntraVascular UltraSound
Sponsored by
Young-Hak Kim, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring OCT, IVUS, BVS

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center
  • Pusan National University Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Optical coherent tomography

IntraVascular UltraSound

Arm Description

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.

Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.

Outcomes

Primary Outcome Measures

OCT-measured in-scaffold minimal lumen area

Secondary Outcome Measures

OCT-measured minimal scaffold area (MSA)
OCT-measured mean scaffold expansion

Full Information

First Posted
June 16, 2016
Last Updated
September 5, 2018
Sponsor
Young-Hak Kim, MD, PhD
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02814578
Brief Title
Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
Acronym
ACTIV-BVS
Official Title
Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
OCT cost is high
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Young-Hak Kim, MD, PhD
Collaborators
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
OCT, IVUS, BVS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optical coherent tomography
Arm Type
Experimental
Arm Description
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.
Arm Title
IntraVascular UltraSound
Arm Type
Active Comparator
Arm Description
Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.
Intervention Type
Other
Intervention Name(s)
Optical coherent tomography
Intervention Description
comparative method for BVS
Intervention Type
Other
Intervention Name(s)
IntraVascular UltraSound
Intervention Description
The method of goldstandard for decision stent choice
Primary Outcome Measure Information:
Title
OCT-measured in-scaffold minimal lumen area
Time Frame
1 year
Secondary Outcome Measure Information:
Title
OCT-measured minimal scaffold area (MSA)
Time Frame
1 year
Title
OCT-measured mean scaffold expansion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-Gu
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.

Learn more about this trial

Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation

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