Study 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.
Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation
1 other identifier
interventional
123
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedStudy Start
First participant enrolled
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2018
CompletedJanuary 15, 2019
January 1, 2019
1.5 years
September 5, 2016
January 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 second after angiographic scaffold optimization is obtained
Study Arms (2)
Angiography-guidance
ACTIVE COMPARATOROCT-guidance
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722, South Korea
Related Publications (1)
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.
PMID: 32525410DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2016
First Posted
September 9, 2016
Study Start
September 12, 2016
Primary Completion
February 26, 2018
Study Completion
February 26, 2018
Last Updated
January 15, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share