Coronary Artery DiseaseNCT02796157
A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
A study testing PCI with Absorb everolimus-eluting bioresorbable vascular scaffold and PCI with Xience everolimus-eluting metallic stent in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PCI with Absorb everolimus-eluting bioresorbable vascular scaffold and PCI with Xience everolimus-eluting metallic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to May 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-85 years
- Patients with ischemic heart disease requiring PCI
- Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
- Reference vessel diameter of 2.5 to 3.75 mm by operator assessment
Who cannot join
- Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
- Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
- Treated with any metallic stent or BVS within 3 months at other vessel
- Cardiogenic shock
- Left ventricular ejection fraction <40%
Show all 9Show fewer
- Pregnant women or women with potential childbearing
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed content
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
MYEONG-KI HONG, MD, 82-2-2228-8458, MKHONG61@yuhs.ac
About this study
PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.
- Conditions
- Coronary Artery Disease
- Being tested
- PCI with Absorb everolimus-eluting bioresorbable vascular scaffold, PCI with Xience everolimus-eluting metallic stent
- Keywords
- bioresorbable vascular scaffold, drug eluting stent, 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.
PCI with Absorb everolimus-eluting bioresorbable vascular scaffoldDevice
Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.
PCI with Xience everolimus-eluting metallic stentDevice
Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.
| Study group | Role | What they receive |
|---|---|---|
| absorb arm | Active comparator | PCI with Absorb everolimus-eluting bioresorbable vascular scaffold Receives: Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold |
| Xience arm | Experimental | PCI with Xience everolimus-eluting metallic stent Receives: Device: PCI with Xience everolimus-eluting metallic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite of major adverse cardiovascular events
Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)
Measured: 1 year after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796157
- Sponsor's protocol ID
- 1-2016-0025
- Status last verified
- May 2018
- First submitted
- 7 Jun 2016
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Seo J, Ahn JM, Hong SJ, Kang DY, Hong SJ, Her AY, Kim YH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Park DW, Hong MK. Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings. Am J Cardiol. 2020 Jun 1;125(11):1624-1630. doi: 10.1016/j.amjcard.2020.02.031. Epub 2020 Mar 15.
PubMed 32279841
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
- ClinicalTrials.gov ID
- NCT02796157
- Acronym / sponsor ID
- 1-2016-0025
- Conditions
- Coronary Artery Disease
- Keywords
- bioresorbable vascular scaffold, drug eluting stent, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 10 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.
PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| absorb arm | Active comparator | Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffoldPCI with Absorb everolimus-eluting bioresorbable vascular scaffold |
| Xience arm | Experimental | Device: PCI with Xience everolimus-eluting metallic stentPCI with Xience everolimus-eluting metallic stent |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19-85 years
- Patients with ischemic heart disease requiring PCI
- Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
- Reference vessel diameter of 2.5 to 3.75 mm by operator assessment
Key exclusion criteria (9 listed)
- Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
- Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
- Treated with any metallic stent or BVS within 3 months at other vessel
- Cardiogenic shock
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 |
|---|---|---|
| PCI with Absorb everolimus-eluting bioresorbable vascular scaffoldPatients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion. | Device | absorb arm |
| PCI with Xience everolimus-eluting metallic stentPatients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion. | Device | Xience arm |
Primary outcome
Incidence of composite of major adverse cardiovascular events
Time frame: 1 year after PCI
Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Derived from this study: PubMed 32279841Seo J, Ahn JM, Hong SJ, Kang DY, Hong SJ, Her AY, Kim YH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Park DW, Hong MK. Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings. Am J Cardiol. 2020 Jun 1;125(11):1624-1630. doi: 10.1016/j.amjcard.2020.02.031. Epub 2020 Mar 15.
- 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.
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI with Absorb everolimus-eluting bioresorbable vascular scaffold and PCI with Xience everolimus-eluting metallic stent in people with Coronary Artery Disease, run by Yonsei University 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 9 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: status not confirmed, as of the sponsor's last update on 18 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite of major adverse cardiovascular events (time frame: 1 year after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796157, which also lists 1 linked publication.
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 18 May 2018.