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DCB Angioplasty for Coronary Lesions: an OCT Analysis

NCT04984135 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2021-08-16

No results posted yet for this study

Summary

In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.

Conditions

  • Coronary Stenosis
  • Drug-coated Balloon

Interventions

PROCEDURE

Percutaneous coronary intervention

All patients were treated with a loading dose of clopidogrel 300 or 600 mg before the procedure followed by maintenance clopidogrel 75 mg daily for 6 months. 100 U/ kg of unfractionated heparin was injected intravenously to maintain an activated clotting time ≥ 250 s during the procedure. For DCB treatment, the patient underwent predilation with an optimal-sized balloon (non-compliant balloon or cutting balloon) based on angiography (balloon-to-vessel ratio of 1.0), with the standard balloon shorter than the intended DCB size. The DCB was sized at 1:1 balloon-to-vessel ratio, delivered rapidly (median of 15 s) and inflated at nominal pressure for 60 s.

Sponsors & Collaborators

  • The First Affiliated Hospital of Dalian Medical University

    lead OTHER

Principal Investigators

  • Lei Guo, MD · The First Affiliated Hospital of Dalian Medical University

Eligibility

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

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-07-01
Completion
2021-07-20

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 NCT04984135 on ClinicalTrials.gov