DCB Compared Stenting in Popliteal Lesions

Not Applicable

• Conditions: Popliteal Stenosis; Diabetes; Popliteal Artery Occlusion
• Interventions: Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.); Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)

• Registration Number: NCT03739580
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Primary Completion: 2018-12-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug-coating balloon	DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)	drug-coating balloon (Orchid) intervention
stent deployment	Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)	metal bare stent intervention

Primary Outcome Measures

Name	Time	Method
Salvage limb rate (for CLI patients)	12 months after the index procedure	Limb Salvage is defined as the freedom from secondary major amputation
Primary patency of claudicant patients	12 months after the index procedure	Claudicant patients (Rutherford C1-3), primary patency defined as PSVR（peak systolic velocity ratio) ≤2.4, absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months

Secondary Outcome Measures

Name	Time	Method
TcpO2	12 months	transcutaneous oxygen pressure
Wagnar classification	12 months	incision healing information of Rutherford C5-6 patients
ABI	12 months	Ankle Brachial index
Rutherford classification	12 months
Index Limb Ischemia at 12-month Follow up	12 months	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Major Adverse Events at 12-month Post Procedure	12 months	Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.
Target vessel revascularization rate	12 months	frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel

Trial Locations

Locations (1)

Gu Yong Quan; 🇨🇳 Beijing, Beijing, China