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Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons

NCT04986098 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2021-08-02

No results posted yet for this study

Summary

DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe \[8\], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. The combined application of DA and DCB in the treatment of peripheral arterial disease has a good early and mid-term effect. Konstantinos et al. reported that DARRT has a higher first-phase patency rate compared with DCB. A retrospective study by Sebastian et al. showed that compared with PTA after DA, the combination of DA and DCB has a better event-free survival rate after 12 months of follow-up. Therefore, DA combined with DCB therapy may be one of the best and most promising methods for the treatment of lower extremity ASO.

Conditions

  • Peripheral Vascular Diseases

Interventions

DEVICE

TurboHawk

Directly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel

DRUG

Paclitaxel

Paclitaxel

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04986098 on ClinicalTrials.gov