Coronary StenosisHOWTO-BRSNCT03175523
HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance
A study testing quantitative coronary angiography guided Bioresorbable scaffold implantation and imaging guided Bioresorbable scaffold implantation in people with Coronary Stenosis, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
The objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- quantitative coronary angiography guided Bioresorbable scaffold implantation and imaging guided Bioresorbable scaffold implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2017to 7 Jul 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 19 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 less and reference vessel diameter of 2.5 ~ 3.75mm by 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.
Who cannot join
- Angiographic exclusion criteria: any of the followings
- Small vessel: mean reference size < 2.5 mm by 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, or left circumflex artery
- Impaired delivery of the Absorb bio- resorbable vascular scaffold is expected:
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- 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.
- 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 or ischemic stroke within the past 6 months
- A known intolerance to a study drug (aspirin, clopidogrel or ticagrelor)
- Patients requiring long-term oral anticoagulants or cilostazol
- Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate(ADP) antagonist is planned within 12 months after the procedure.
- A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times upper limit of normal).
- Life expectancy < 5 years for any non-cardiac or cardiac causes
- Unwillingness or inability to comply with the procedures described in this protocol.
- Patient's pregnant or breast-feeding or child-bearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation.
Read the detailed description
The investigators hypothesized that intravascular imaging-guided BRS implantation is superior to QCA-guided BRS implantation with respect to target lesion failure in patients with native coronary artery disease.
- Conditions
- Coronary Stenosis
- Being tested
- quantitative coronary angiography guided Bioresorbable scaffold implantation, imaging guided Bioresorbable scaffold implantation
- Keywords
- BioResorbable Scaffold, Quantitative Coronary Angiography, Intravascular Imaging
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitative coronary angiography guided Bioresorbable scaffold implantationDevice
In the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections.
imaging guided Bioresorbable scaffold implantationDevice
In the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory.
| Study group | Role | What they receive |
|---|---|---|
| Imaging guided Bioresorbable scaffold | Active comparator | Not described Receives: Device: imaging guided Bioresorbable scaffold implantation |
| QCA-guided Bioresorbable scaffold | Experimental | quantitative coronary angiography guided Bioresorbable scaffold Receives: Device: quantitative coronary angiography guided Bioresorbable scaffold implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (11)
Device success
Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA).
Measured: 1 hour after an index procedure
Procedural success
Achievement of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel myocardial infarction or repeat target lesion revascularization during the hospital stay.
Measured: 24 hours after an index procedure
Death
cardiac, vascular, non-cardiovascular
Measured: 1 year, and 5 years
Myocardial infarction
Measured: 1 year, and 5 years
Scaffold thrombosis
Measured: 1 year, and 5 years
Stroke
Measured: 1 year, and 5 years
Target lesion revascularization
Measured: 1 year, and 5 years
Any revascularization
Measured: 1 year, and 5 years
Target lesion failure (TLR)
cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization
Measured: 1 year, and 5 years
A composite event
a composite event of cardiac death, target vessel myocardial infarction, stroke, or clinically significant bleeding(clinically significant bleeding by Bleeding Academic Research Consortium (BARC) type 2,3,4,5)
Measured: 1 year, and 5 years
In-scaffold restenosis on coronary CT angiography
Measured: 1 year, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start29 Sep 2017
- Primary completion20 Feb 2019
- Study completion7 Jul 2022
Why it stopped: BioResorbable Scaffold is not available in South Korea
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
- Investigators
- Yang-soo Jang, MD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175523
- Sponsor's protocol ID
- AMCCV2017-03
- Acronym
- HOWTO-BRS
- Status last verified
- Jul 2022
- First submitted
- 31 May 2017
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance
- ClinicalTrials.gov ID
- NCT03175523
- Acronym / sponsor ID
- HOWTO-BRS / AMCCV2017-03
- Conditions
- Coronary Stenosis
- Keywords
- BioResorbable Scaffold, Quantitative Coronary Angiography, Intravascular Imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: BioResorbable Scaffold is not available in South Korea
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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 objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation.
Detailed description
The investigators hypothesized that intravascular imaging-guided BRS implantation is superior to QCA-guided BRS implantation with respect to target lesion failure in patients with native coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaging guided Bioresorbable scaffold | Active comparator | Device: imaging guided Bioresorbable scaffold implantation |
| QCA-guided Bioresorbable scaffold | Experimental | Device: quantitative coronary angiography guided Bioresorbable scaffold implantationquantitative coronary angiography guided Bioresorbable scaffold |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women at least 19 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 less and reference vessel diameter of 2.5 ~ 3.75mm by 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.
Key exclusion criteria (26 listed)
- Angiographic exclusion criteria: any of the followings
- 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%
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 |
|---|---|---|
| quantitative coronary angiography guided Bioresorbable scaffold implantationIn the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections. | Device | QCA-guided Bioresorbable scaffold |
| imaging guided Bioresorbable scaffold implantationIn the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory. | Device | Imaging guided Bioresorbable scaffold |
Primary outcome
Target lesion failure
Time frame: 1 year
the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.
11 secondary outcomes
Device success
Time frame: 1 hour after an index procedure
Procedural success
Time frame: 24 hours after an index procedure
Death
Time frame: 1 year, and 5 years
Myocardial infarction
Time frame: 1 year, and 5 years
Scaffold thrombosis
Time frame: 1 year, and 5 years
Stroke
Time frame: 1 year, and 5 years
Target lesion revascularization
Time frame: 1 year, and 5 years
Any revascularization
Time frame: 1 year, and 5 years
Target lesion failure (TLR)
Time frame: 1 year, and 5 years
A composite event
Time frame: 1 year, and 5 years
In-scaffold restenosis on coronary CT angiography
Time frame: 1 year, and 5 years
Results and safety
The study was stopped early (reason given: BioResorbable Scaffold is not available in South Korea). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Yang-soo Jang, MD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quantitative coronary angiography guided Bioresorbable scaffold implantation and imaging guided Bioresorbable scaffold implantation in people with Coronary Stenosis, run by Seung-Jung Park at 1 site 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 26 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: BioResorbable Scaffold is not available in South Korea). 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?
Target lesion failure (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 8 Jul 2022.