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Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions

NCT05868564 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-22

No results posted yet for this study

Summary

The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Atherectomy+Drug-coated balloon

Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group

DEVICE

Drug-coated balloon

drug-coated balloon only in the active comparator group.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Qingdao Hiser Medical Group

    collaborator OTHER

  • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Meng Ye, M.D. · Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2027-07-31
Completion
2027-07-31

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 NCT05868564 on ClinicalTrials.gov