View clinical trials related to Femoropopliteal Artery Disease.
Filter by:- Prospective, multi-center, randomized, controlled comparison study - A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions. - Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year. - Patients will be followed clinically for 2 years after the procedure.
- Prospective, randomized, controlled, multi-center study - A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria. - Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group. - Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional - All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions. - Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis. - Patients will be followed clinically for 1 year after the procedure. - Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
- Prospective, randomized, controlled, multi-center study - A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria. - Patients will be randomized in a 1:1 manner into long stenting group versus short stenting group. and treated with Zilver PTX for long femoropopliteal lesions - Patients will be followed clinically for 1 year after the procedure. - Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
- Prospective, single-arm, multi-center registry study - A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included. - Patients will be followed clinically for 12 months after the procedure. - Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months. - Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months. - Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)
The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.