An exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery
This Study demonstrate an exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Primary patency of stent at 12 months after the investigational procedure
Loss of primary patency of the stent is determined as any of the following cases. * The case as the peak systolic velocity ratio (PSVR) exceeds 2.4 * The case as the subject had a CDTLR. * The case as the angiography revealed \> 50% lumen diameter stenosis.
Time frame: 12 months
Composite of major adverse events (MAEs) up to 12 months after the investigational procedure
MAE is defined as : * All death within 30 days after the study procedure. * Major amputation of target lower extrimity * Clinically driven target lesion revascurarization.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Osaka Keisatsu Hospital
Osaka City, Osaka, Japan