Sendai Kousei Hospital | Clinical Trial Management Office
Status
Conditions
Treatments
About
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal (POP) artery, which would be otherwise ineligible for endovascular therapy due to risk of complication. Study objective is to collect safety and effectiveness data to support potential commercialization of the peripheral OAS device in Japan.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
General Inclusion Criteria (≤30 Days from Clinical Trial Treatment):
General Exclusion Criteria (≤30 Days from Clinical Trial Treatment):
Clinical Trial Treatment Inclusion:
Clinical Trial Treatment Exclusion:
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Loading...
Central trial contact
Clinical Trial Lead
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal