An interventional study of SoundBite Crossing System in Chronic Total Occlusion of Artery of the Extremities, sponsored by SoundBite Medical Solutions, Inc.. Recruiting at 5 sites in 3 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by SoundBite Medical Solutions, Inc. · Not applicable, Interventional, and Treatment
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.
The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 130 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →SoundBite Medical Solutions, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries:
Presenting with the following:
Exclusion Criteria:
Any medical condition that would make subject an inappropriate candidate for interventional treatment as determined by the Investigator, including the following:
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee)
Device: SoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee)
Device: SoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
Device Performance
Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)
Time frame: Day 0
Device Safety
Procedural incidence of any of the following: no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment
Time frame: Day 0
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)
Time frame: 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)
Time frame: Day 0
Acute Lumen Gain
Difference in final minimal lumen diameter compared to baseline
Time frame: Day 0
Residual Percent Stenosis
Final percent stenosis at procedure end
Time frame: Day 0
Procedure Time
First groin puncture to final sheath removal
Time frame: Day 0
Fluoroscopy Time
Time frame: Day 0
Number of Devices Used
Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents
Time frame: 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
Time frame: Day 30 (+10/-0 days)
Plan to share: No
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SoundBite Medical Solutions, Inc.