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Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China

NCT04641468 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-27

No results posted yet for this study

Summary

This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.

Conditions

  • Coronary Diseases
  • Left Main Coronary Artery Disease
  • Bifurcation Lesions

Interventions

PROCEDURE

DCB

OCT technical guidance: if B-type or C-type dissection can be seen, Oct should be used for further evaluation, and des treatment should be conducted if necessary

Sponsors & Collaborators

  • Xuzhou Third People's Hospital

    lead OTHER

Principal Investigators

  • yaojun zhang, doctor · Head of Cardiology Department of Xuzhou Third People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-12-31
Completion
2021-12-31

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 NCT04641468 on ClinicalTrials.gov