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Effect of TCFA on Neointimal Coverage After PCI at 9 Months Follow-up

NCT02384837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2016-12-06

No results posted yet for this study

Summary

Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared with bare metal stents, late stent thrombosis (LST), a life-threatening complication of this technology, has emerged as a major concern. Researches indicated incomplete neointimal coverage of stent struts as the most important morphometric predictor of LST. Pathological research showed stenting disruption of adjacent vulnerable plaques can precipitate LST, Meanwhile, thin-cap fibroatheromas (TCFA) as the most important predictor of Major Adverse Cardiovascular. Therefore, there is a hypothesis that TCFA may impair intimal healing which are prone to LST in vivo.

Optical coherence tomography (OCT)is a high-resolution (\<10 µm), catheter-based imaging modality capable of investigating detailed coronary plaque morphology in vivo.This study aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts on the lesions which fractional flow reserve (FFR)≤0.75 after EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted at 9 months follow up: evaluated by OCT and FFR

Conditions

  • Unrecognized Condition

Interventions

DEVICE

EXCEL biodegradable polymer-coated sirolimus-eluting stent

Sponsors & Collaborators

  • General Hospital of Chinese Armed Police Forces

    lead OTHER

Principal Investigators

  • HUILIANG LIU, MD · CHINESE ARMED POLICE FORCE GENRAL HOSPITAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02384837 on ClinicalTrials.gov