Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation

Not Applicable

Terminated

• Conditions: Myocardial Ischemia
• Interventions: Device: Optical coherence tomography-guided PCI with BVS; Device: Angiography-guided PCI with BVS

• Registration Number: NCT02894697
• Lead Sponsor: Yonsei University

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.

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 Timeline

• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Study Start: 2016-09-12
• Primary Completion: 2018-02-26
• Study Completion: 2018-02-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCT-guidance	Optical coherence tomography-guided PCI with BVS	-
Angiography-guidance	Angiography-guided PCI with BVS	-

Primary Outcome Measures

Name	Time	Method
An incidence of OCT-defined suboptimization of BVS requiring additional BVS	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

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of