Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion

Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study

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.

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.