Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions
This is a prospective, multi-center, non-randomized, open label, single arm post-market clinical study to gather data on the use of the Protexus catheter for temporary blood vessel occlusion while standard of care treatment with other therapeutic devices is conducted in patients undergoing infrapopliteal treatment for peripheral arterial disease (PAD).
Study Type
OBSERVATIONAL
Enrollment
20
Primary Endpoint
The incidence, type, and severity of Protexus related major adverse events (MAEs) through 30-days defined as: * Death or organ injury * Thrombosis, pseudo-aneurysm, dissection (grade C or greater by visual assessment) or clinical perforation at the Protexus device location * Angiographically evident flow limiting distal embolization
Time frame: 30 Days
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