Coronary Artery DiseaseACTIV-BVSNCT02814578
Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
A study testing Optical coherent tomography and IntraVascular UltraSound in people with Coronary Artery Disease, run by Young-Hak Kim, MD, PhD at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Optical coherent tomography and IntraVascular UltraSound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 31 Jul 2017to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Pusan National University Hospital
Pusan
Asan Medical Center
Seoul, Songpa-Gu
Ulsan University Hospital
Ulsan
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Optical coherent tomography, IntraVascular UltraSound
- Keywords
- OCT, IVUS, BVS
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherent tomographyOther
comparative method for BVS
IntraVascular UltraSoundOther
The method of goldstandard for decision stent choice
| Study group | Role | What they receive |
|---|---|---|
| Optical coherent tomography | Experimental | 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. Receives: Other: Optical coherent tomography |
| IntraVascular UltraSound | Active comparator | Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement. Receives: Other: IntraVascular UltraSound |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT-measured in-scaffold minimal lumen area
Measured: 1 year
Secondary outcomes (2)
OCT-measured minimal scaffold area (MSA)
Measured: 1 year
OCT-measured mean scaffold expansion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start31 Jul 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Why it stopped: OCT cost is high
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Young-Hak Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor-investigator, Young-Hak Kim, MD, PhD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814578
- Sponsor's protocol ID
- AMCCV2016-02
- Acronym
- ACTIV-BVS
- Status last verified
- Sep 2018
- First submitted
- 16 Jun 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
- ClinicalTrials.gov ID
- NCT02814578
- Acronym / sponsor ID
- ACTIV-BVS / AMCCV2016-02
- Conditions
- Coronary Artery Disease
- Keywords
- OCT, IVUS, BVS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: OCT cost is high
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Young-Hak Kim, MD, PhDUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optical coherent tomography | Experimental | Other: Optical coherent tomographyOptical 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 | Active comparator | Other: IntraVascular UltraSoundIntravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherent tomographycomparative method for BVS | Other | Optical coherent tomography |
| IntraVascular UltraSoundThe method of goldstandard for decision stent choice | Other | IntraVascular UltraSound |
Primary outcome
OCT-measured in-scaffold minimal lumen area
Time frame: 1 year
2 secondary outcomes
OCT-measured minimal scaffold area (MSA)
Time frame: 1 year
OCT-measured mean scaffold expansion
Time frame: 1 year
Results and safety
The study was stopped early (reason given: OCT cost is high). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherent tomography and IntraVascular UltraSound in people with Coronary Artery Disease, run by Young-Hak Kim, MD, PhD at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: OCT cost is high). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT-measured in-scaffold minimal lumen area (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.