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Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions

NCT04022200 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-03-22

No results posted yet for this study

Summary

Drug-coating balloon (DCB) is a new interventional device for treatment of obstructive coronary artery disease (CAD). There is limited data on the long term efficacy and safety of DCB-only strategy for coronary de novo lesions in Asian patients. We therefore carry out this registry study to evaluated the clinical outcomes of paclitaxel DCB in Chinese patients in a real world medical practice.

Conditions

  • Coronary Disease

Interventions

DEVICE

Paclitaxel DCB

The length of the DCB catheter should be chosen to exceed the target lesion for at least 2mm (at both proximal and distalends). The catheter(s) will be inflated for 30 to 60s with a minimum of 7 atm. Predilation of the diseased coronary segment with a uncoated balloon/scoring balloon/cutting balloon before the use of DCB will be encouraged. DES should be implanted if the angiographic result after DCB alone therapy is not satisfactory due to significant recoil/residual stenosis or dissection (Type C-F).

Sponsors & Collaborators

  • Beijing Hospital

    lead OTHER_GOV

Principal Investigators

  • Xue Yu, MD · Beijing Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2023-01-31
Completion
2023-07-31

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 NCT04022200 on ClinicalTrials.gov