Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion

Last updated: July 30, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Claudication

Vascular Diseases

Treatment

Chocolate balloon

Clinical Study ID

NCT05894460
Chocolate-FP
  • Ages > 18
  • All Genders

Study Summary

This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Rutherford classification of 2-6 in patients with femoropopliteal atheroscleroticocclusive disease;
  • primary cases with no previous surgical treatment of the target lesion;
  • presence of at least one vessel with patency in the distal outflow tract;
  • survival >1 year.

Exclusion

Exclusion Criteria:

  • planned stenting;
  • presence of flow-limiting dissection prior to application of Chocolate balloon andconventional balloon dilation of the target lesion;
  • combination of severe organ dysfunction of the heart, lungs and brain that cannottolerate the procedure;
  • allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs;
  • ineffective recanalization attempts;
  • lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.

Study Design

Total Participants: 254
Treatment Group(s): 1
Primary Treatment: Chocolate balloon
Phase:
Study Start date:
June 27, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Xuanwu Hospital

    Beijing, None Selected 100053
    China

    Active - Recruiting

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