Myocardial IschemiaNCT02894697
Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation
A study testing Angiography-guided PCI with BVS and Optical coherence tomography-guided PCI with BVS in people with Myocardial Ischemia, run by Yonsei University at 1 site in South Korea.
Trial summary
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis. OCT-guidance may improve more optimized scaffold placement and also better outcomes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Angiography-guided PCI with BVS and Optical coherence tomography-guided PCI with BVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Sep 2016to 26 Feb 2018
- 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
- Patients ≥ 19 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single BVS ≤ 28 mm
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Who cannot join
- Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Inability to understand or read the informed content
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis. OCT-guidance may improve more optimized scaffold placement and also better outcomes. However, there is still no sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it should be more evaluated in real practice. In the study, the investigators will evaluate an incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.
Read the detailed description
It is well-known that non-optimal stent implantation associated with under-expansion or incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a higher incidence of restenosis and stent thrombosis. OCT-guided PCI with metallic stent has previously been shown to be safe and feasible, resulting in better clinical outcomes compared with angiography-only guided PCI. Everolimus-eluting bioabsorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. BVS has a number of proposed advantages over current metallic stent technology. These include elimination of chronic sources of vessel irritation and inflammation, which can reduce the potential risk of late scaffold thrombosis after complete scaffold bioresorption. Although the current generation of the Absorb BVS have larger strut thickness of 150 μm compared with 80 μm of strut of Xience stent, the acute recoil of the polymeric device was similar to that of metallic stent. However, operators tented to use dilating devices less aggressively because of the concerns about limitation in elongation-at-break of polylactide.
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis. OCT-guidance may improve more optimized scaffold placement and also better outcomes. However, there is still no sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it should be more evaluated in real practice. In the study, the investigators will evaluate an incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.
- Conditions
- Myocardial Ischemia
- Being tested
- Angiography-guided PCI with BVS, Optical coherence tomography-guided PCI with BVS
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography-guided PCI with BVSDevice
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality. After PCI, postprocedural OCT will be evaluated to find OCT-defined suboptimal results requiring additional PCI. If there is OCT-defined suboptimization, additional PCI will be performed including balloon angioplasty or additional stent or BVS implantation for scaffold optimization. Further postprocedural OCT will be also evaluated whether scaffold implantation is fully optimized or not.
Optical coherence tomography-guided PCI with BVSDevice
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before stent implantation. After PCI, postprocedural OCT will be evaluated to find OCT-defined suboptimal results requiring additional PCI. If there is OCT-defined suboptimization, additional PCI will be performed including balloon angioplasty or additional stent or BVS implantation for scaffold optimization. Further postprocedural OCT will be also evaluated whether scaffold implantation is fully optimized or not.
| Study group | Role | What they receive |
|---|---|---|
| Angiography-guidance | Active comparator | Not described Receives: Device: Angiography-guided PCI with BVS |
| OCT-guidance | Experimental | Not described Receives: Device: Optical coherence tomography-guided PCI with BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
An incidence of OCT-defined suboptimization of BVS requiring additional BVS
An incidence of OCT-defined BVS suboptimization requiring additional PCI
: A composite of minimal scaffold area <5 mm2, residual area stenosis >20%, major edge dissections, incomplete strut apposition and scaffold pattern disruptions
Measured: 1 second after angiographic scaffold optimization is obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start12 Sep 2016
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
Why it stopped: Due to a problem with the supply and demand of the stent used in the study, it is difficult to register the target so the study ends early.
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 Myocardial IschemiaStudies 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894697
- Sponsor's protocol ID
- 1-2016-0038
- Status last verified
- Jan 2019
- First submitted
- 5 Sep 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lee SY, Kang DY, Hong SJ, Ahn JM, Ahn CM, Park DW, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Hong MK. Optical Coherence Tomography for Coronary Bioresorbable Vascular Scaffold Implantation: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Jan;13(1):e008383. doi: 10.1161/CIRCINTERVENTIONS.119.008383. Epub 2020 Jan 9.
PubMed 32525410
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation
- ClinicalTrials.gov ID
- NCT02894697
- Acronym / sponsor ID
- 1-2016-0038
- Conditions
- Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a problem with the supply and demand of the stent used in the study, it is difficult to register the target so the study ends early.
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 9 Sep 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.
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis. OCT-guidance may improve more optimized scaffold placement and also better outcomes. However, there is still no sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it should be more evaluated in real practice. In the study, the investigators will evaluate an incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.
Detailed description
It is well-known that non-optimal stent implantation associated with under-expansion or incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a higher incidence of restenosis and stent thrombosis. OCT-guided PCI with metallic stent has previously been shown to be safe and feasible, resulting in better clinical outcomes compared with angiography-only guided PCI. Everolimus-eluting bioabsorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. BVS has a number of proposed advantages over current metallic stent technology. These include elimination of chronic sources of vessel irritation and inflammation, which can reduce the potential risk of late scaffold thrombosis after complete scaffold bioresorption. Although the current generation of the Absorb BVS have larger strut thickness of 150 μm compared with 80 μm of strut of Xience stent, the acute recoil of the polymeric device was similar to that of metallic stent. However, operators tented to use dilating devices less aggressively because of the concerns about limitation in elongation-at-break of polylactide.
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis. OCT-guidance may improve more optimized scaffold placement and also better outcomes. However, there is still no sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it should be more evaluated in real practice. In the study, the investigators will evaluate an incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography-guidance | Active comparator | Device: Angiography-guided PCI with BVS |
| OCT-guidance | Experimental | Device: Optical coherence tomography-guided PCI with BVS |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 19 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single BVS ≤ 28 mm
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Key exclusion criteria (6 listed)
- Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
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 |
|---|---|---|
| Angiography-guided PCI with BVSEverolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality. After PCI, postprocedural OCT will be evaluated to find OCT-defined suboptimal results requiring additional PCI. If there is OCT-defined suboptimization, additional PCI will be performed including balloon angioplasty or additional stent or BVS implantation for scaffold optimization. Further postprocedural OCT will be also evaluated whether scaffold implantation is fully optimized or not. | Device | Angiography-guidance |
| Optical coherence tomography-guided PCI with BVSEverolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before stent implantation. After PCI, postprocedural OCT will be evaluated to find OCT-defined suboptimal results requiring additional PCI. If there is OCT-defined suboptimization, additional PCI will be performed including balloon angioplasty or additional stent or BVS implantation for scaffold optimization. Further postprocedural OCT will be also evaluated whether scaffold implantation is fully optimized or not. | Device | OCT-guidance |
Primary outcome
An incidence of OCT-defined suboptimization of BVS requiring additional BVS
Time frame: 1 second after angiographic scaffold optimization is obtained
An incidence of OCT-defined BVS suboptimization requiring additional PCI : A composite of minimal scaffold area <5 mm2, residual area stenosis >20%, major edge dissections, incomplete strut apposition and scaffold pattern disruptions
Results and safety
The study was stopped early (reason given: Due to a problem with the supply and demand of the stent used in the study, it is difficult to register the target so the study ends early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 32525410Lee SY, Kang DY, Hong SJ, Ahn JM, Ahn CM, Park DW, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Hong MK. Optical Coherence Tomography for Coronary Bioresorbable Vascular Scaffold Implantation: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Jan;13(1):e008383. doi: 10.1161/CIRCINTERVENTIONS.119.008383. Epub 2020 Jan 9.
- Individual participant dataSharing planned: No
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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 Angiography-guided PCI with BVS and Optical coherence tomography-guided PCI with BVS in people with Myocardial Ischemia, 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 6 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 15 Jan 2019. 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: Due to a problem with the supply and demand of the stent used in the study, it is difficult to register the target so the study ends early.). 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?
An incidence of OCT-defined suboptimization of BVS requiring additional BVS (time frame: 1 second after angiographic scaffold optimization is obtained). 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 NCT02894697, 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 15 Jan 2019.