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

Last updated: January 11, 2019
Sponsor: Yonsei University
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Vascular Diseases

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT02894697
1-2016-0038
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 19 years old

  • Patients with ischemic heart disease who are considered for coronary revascularizationwith PCI

  • Significant coronary de novo lesion (stenosis > 70% by quantitative angiographicanalysis) treated by single BVS ≤ 28 mm

  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion

Exclusion Criteria:

  • Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic totalocclusion, 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

Study Design

Total Participants: 123
Study Start date:
September 12, 2016
Estimated Completion Date:
February 26, 2018

Study 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.

Connect with a study center

  • Severance Cardiovascular Hospital, Yonsei University College of Medicine

    Seoul, 03722
    Korea, Republic of

    Site Not Available

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