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Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions

NCT04744571 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-02-09

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions patients with chronic total occlusion (CTO) lesion.

Conditions

  • Coronary Artery Disease
  • Coronary Occlusion
  • Percutaneous Coronary Intervention
  • Chronic Total Occlusion of Coronary Artery
  • Drug-Eluting Stents

Interventions

DRUG

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate- limiting medication (i.e. Beta- blocker or rate-limiting calcium antagonist) where appropriate. Anti- anginal therapy should be used if the patients have symptom.

DEVICE

coronary wires. or coronary balloons

all species of coronary wires, or plain balloons

OTHER

drug-coated balloon

Drug-coated balloon including all sizes and all brands

DEVICE

drug-eluting stent

Drug-eluting stent including all sizes and all brands

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • xiantao song, MD · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04744571 on ClinicalTrials.gov