Diabetes, Popliteal Artery Occlusion, Popliteal Stenosis
Conditions
Keywords
drug-coating balloon, stent, popliteal artery, atherosclerotic occlusion
Brief summary
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
Interventions
DEVICEDCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
DEVICEStent (Maris,Medtronic.USA or Sinus/Supera, Germany)
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Salvage limb rate (for CLI patients) | 12 months after the index procedure | Limb Salvage is defined as the freedom from secondary major amputation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TcpO2 | 12 months | transcutaneous oxygen pressure |
| Wagnar classification | 12 months | incision healing information of Rutherford C5-6 patients |
| 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 |
| ABI | 12 months | Ankle Brachial index |
Countries
China
Contacts
Primary ContactJianming Guo, M.D.
Outcome results
None listed