DCB Compared Stenting in Popliteal Lesions

Capital Medical University

Status: Unknown

Conditions: Popliteal Artery Occlusion; Diabetes; Popliteal Stenosis

Treatments: Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.); Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT03739580

DBSP-XWHCMU

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 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 the anterior 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 bleeding diathesis
• 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 (more than 50% stenosis or occlusion)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

drug-coating balloon

Experimental group

Description:

drug-coating balloon (Orchid) intervention

Treatment:

Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)

stent deployment

Active Comparator group

Description:

metal bare stent intervention

Treatment:

Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)