Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion (NCT05894460) | Clinical Trial Compass
UnknownNot Applicable
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
China254 participantsStarted 2023-06-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.