Peripheral Arterial Disease
Conditions
Keywords
Femoral artery, Popliteal artery, Peripheral artery disease, Chocolate percutaneous transluminal angioplasty balloon, Drug-coated balloon
Brief 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.
Interventions
DEVICEChocolate balloon
Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty
Sponsors
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive 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 criteria
* planned stenting; * presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion; * combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 months | No occlusion or restenosis (\>50%) of the target vessel in the treated segment during follow-up and no further intervention is required. |
Countries
China
Outcome results
None listed