This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)
A first-in-human, single-arm, single-center, feasibility study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 10 patients meeting the inclusion/exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.
INDEN
Santo Domingo, Dominican Republic
Technical Success (On Procedure Day)
Ability of the FastWire to successfully cross angiographically confirmed chronic total occlusions and provide a platform for delivery of other treatment devices.
Time frame: Day 1
Clinical success (On Procedure Day)
Clinical success is assessed as the angiographically confirmed passage of the FastWire tip through the lesion and the successful delivery and retrieval of FastWire and the delivery of a treatment device to the target site.
Time frame: Day 1
Freedom from Serious Adverse Events related to the use of FastWire, at 30 days post procedure:
* Cardiovascular deaths. * Vessel dissection requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization.
Time frame: Up to Day 30
Freedom from Serious Adverse Device Effects (SADE) (Up to Day 30)
Freedom from Serious Adverse Device Effects (SADE).
Time frame: Up to Day 30
Freedom from Vessel dissection or bleeding (Within 24 Hours)
Freedom from Vessel dissection or bleeding within 24 hours (16-36 hours) of index procedure.
Time frame: Within 24 Hours
Procedural success (On Procedure Day)
Procedural success, defined as achievement of technical success together with post procedure patency (less than 50% residual diameter stenosis of target vessel patent as assessed by angiographic imaging post device retrieval.
Time frame: Day 1
Procedure related mortality (Up to Day 7 & Day 30)
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All procedure related mortality at day 7 post procedure, and all-cause mortality at 30 days post procedure.
Time frame: Up to Day 7 & Day 30