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Lesion Preparation in Femoropopliteal Artery Occlusion Disease

NCT05473884 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2022-11-07

No results posted yet for this study

Summary

Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.

Conditions

  • Femoropopliteal Artery Occlusion
  • Atherosclerosis Obliterans
  • Lesion; Vascular
  • In-stent Restenosis

Interventions

DEVICE

lesion preparation devices

successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty

DEVICE

conventional balloon

Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

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

    collaborator OTHER

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • Qingdao Hiser Medical Group

    collaborator OTHER

  • Shanghai Pudong Hospital

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-05-31
Completion
2024-05-31

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 NCT05473884 on ClinicalTrials.gov