Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Study Overview
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Brief Summary
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Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.

Detailed Description
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The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)

Official Title
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Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Conditions
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Chronic Total Occlusion of Artery of the Extremities

Intervention / Treatment
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* Device: SoundBite Crossing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries: CaTO-PAD: infrainguinal CaTO-BTK: infrapopliteal Have at least one chronic total occlusion (CTO) with no flow observed in the distal lesion except the flow from collateral circulation Presenting with the following: CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb CaTO-BTK Sub-Study: - Category 4 or 5 only for CaTO-BTK Sub-Study CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb Age of > 18 years Have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form Target lesion calcification is at least moderate by PARC definition (see Section 15) Target lesion is refractory as demonstrated by a failed attempt with a guidewire Exclusion Criteria: Any medical condition that would make subject an inappropriate candidate for interventional treatment as determined by the Investigator, including the following: Glomerular filtration rate <30 ml/min Mortality expected within 30 days Already enrolled in an investigational interventional study that would interfere with study endpoints Target lesion is crossed intraluminally with a conventional guidewire Treatment of an inflow lesion prior to target lesion treatment results in no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment Women who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SoundBite Crossing System - PAD<br>Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee) | Device: SoundBite Crossing System<br>* Use of the SoundBite Crossing System to cross calcified chronic total occlusions<br>|
| Experimental: SoundBite Crossing System - BTK<br>Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee) | Device: SoundBite Crossing System<br>* Use of the SoundBite Crossing System to cross calcified chronic total occlusions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Performance | Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde) | Day 0 | 
| Device Safety | Procedural incidence of any of the following: no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antegrade Crossing | Placement of a guidewire distal to the lesion in the true lumen (Note: retrograde crossing is allowed, but is considered a failure for this endpoint) | Day 0 | 
| CTO Crossing Time | From first engagement of proximal cap with the Active Wire to guidewire in distal true lumen (or decision made to discontinue attempts) | Day 0 | 
| Acute Lumen Gain | Difference in final minimal lumen diameter compared to baseline | Day 0 | 
| Residual Percent Stenosis | Final percent stenosis at procedure end | Day 0 | 
| Procedure Time | First groin puncture to final sheath removal | Day 0 | 
| Fluoroscopy Time |  | Day 0 | 
| Number of Devices Used | Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents | Day 0 | 
| Secondary Safety Endpoint | Rate of 30-day major adverse events (MAE) consisting of: death, emergency surgical revascularization of the target limb, unplanned amputation of the target limb, symptomatic distal thrombus or emboli requiring intervention, perforation requiring treatment | Day 30 (+10/-0 days) |