Percutaneous Transluminal Coronary AngioplastyGUIDE-BVSNCT02831218
Quantitative Coronary Angiography Versus Imaging GUIDancE for Bioresorbable Vascular Scaffold Implantation
A study testing QCA and Aspirin, QCA and Clopidogrel and Imaging guided and Aspirin in people with Percutaneous Transluminal Coronary Angioplasty, run by Seung-Jung Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Transluminal Coronary Angioplasty
- What is being tested?
- QCA and Aspirin, QCA and Clopidogrel and Imaging guided and Aspirin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Angiographic exclusion criteria: any of the followings
- 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:
Show all 25Show fewer
- 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
- 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 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 (ALT or 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 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.
- Being tested
- QCA and Aspirin, QCA and Clopidogrel, Imaging guided and Aspirin, Imaging guided and Clopidogrel
- Keywords
- bioresorbable vascular scaffold, coronary artery disease
- 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.
QCA and AspirinProcedure or surgery
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 ClopidogrelProcedure or surgery
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.
Imaging guided and AspirinProcedure or surgery
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 ClopidogrelProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| QCA and Aspirin alone | Experimental | Not described Receives: Procedure: QCA and Aspirin |
| QCA and Clopidogrel alone | Experimental | Not described Receives: Procedure: QCA and Clopidogrel |
| Imaging guided and Aspirin alone | Active comparator | Not described Receives: Procedure: Imaging guided and Aspirin |
| Imaging guided and Clopidogrel alone | Active comparator | Not described Receives: Procedure: Imaging guided and Clopidogrel |
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 (10)
Device success
Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA).
Measured: 1 day
Procedural success
Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA with successful delivery and deployment of at least one study scaffold/stent 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 (24 hour after an index procedure).
Measured: 24 hours
Death
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
cardiac death, target vessel myocardial infarction or ischemia-driven target lesion failure
Measured: 1 year and 5 years
event rate of net clinical events
defined as composite event of cardiovascular death, myocardial infarction, stroke, clinically relevant bleeding
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: This study was merged into HOWTO-BRS study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Transluminal Coronary AngioplastyStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831218
- Sponsor's protocol ID
- AMCCV2016-13
- Acronym
- GUIDE-BVS
- Status last verified
- Jan 2018
- First submitted
- 6 Jul 2016
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Coronary Angiography Versus Imaging GUIDancE for Bioresorbable Vascular Scaffold Implantation
- ClinicalTrials.gov ID
- NCT02831218
- Acronym / sponsor ID
- GUIDE-BVS / AMCCV2016-13
- Keywords
- bioresorbable vascular scaffold, coronary artery disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was merged into HOWTO-BRS study.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- Angiographic exclusion criteria: any of the followings
- 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)
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 |
|---|---|---|
| QCA and AspirinQCA(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. | Procedure or surgery | QCA and Aspirin alone |
| QCA and ClopidogrelQCA(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. | Procedure or surgery | QCA and Clopidogrel alone |
| Imaging guided and AspirinBVS 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. | Procedure or surgery | Imaging guided and Aspirin alone |
| Imaging guided and ClopidogrelBVS 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. | Procedure or surgery | Imaging guided and Clopidogrel alone |
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.
10 secondary outcomes
Device success
Time frame: 1 day
Procedural success
Time frame: 24 hours
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
Time frame: 1 year and 5 years
event rate of net clinical events
Time frame: 5 years
Results and safety
The study was stopped early (reason given: This study was merged into HOWTO-BRS study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QCA and Aspirin, QCA and Clopidogrel and Imaging guided and Aspirin in people with Percutaneous Transluminal Coronary Angioplasty, 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 25 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 5 Jan 2018. 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: This study was merged into HOWTO-BRS study.). 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 5 Jan 2018.