DCB Compared Stenting in Popliteal Lesions

Last updated: November 13, 2018
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Foot Ulcers

Diabetic Neuropathy

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT03739580
DBSP-XWHCMU
  • Ages 18-80
  • All Genders

Study Summary

This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older

  • Symptomatic peripheral artery disease:

  • Moderate or severe claudication (Rutherford category 2 or 3)

  • Critical limb ischemia (Rutherford category 4 or 5)

  • Atherosclerotic popliteal artery disease (stenosis > 50%)

  • Patients with signed informed consent

Exclusion

Exclusion Criteria:

  • Acute critical limb ischemia

  • Severe critical limb ischemia (Rutherford category 6)

  • Involvement of SFA disease with stenosis

  • Continous total occlusion of all proximal infrapopliteal arteries (origin of theanterior tibial artery or tibioperoneal trunk).

  • Known hypersensitivity or contraindication to any of the following medications:heparin, aspirin, clopidogrel, or contrast agent

  • Age > 80 years

  • Severe hepatic dysfunction (> 3 times normal reference values)

  • Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleedingdiathesis

  • LVEF < 40% or clinically overt congestive heart failure

  • Pregnant women or women with potential childbearing

  • Life expectancy <1 year due to comorbidity

  • Previous bypass surgery or stenting for the target popliteal artery

  • Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (morethan 50% stenosis or occlusion)

Study Design

Total Participants: 80
Study Start date:
October 01, 2016
Estimated Completion Date:
September 01, 2019

Connect with a study center

  • Gu Yong Quan

    Beijing, Beijing 100053
    China

    Active - Recruiting

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