RecruitingNot Applicable

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

United States, Austria, Germany130 participantsStarted 2023-02-21

Plain-language summary

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.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

What they're measuring

Device Performance

Timeframe: Day 0

Device Safety

Timeframe: Day 0

Trial details

NCT IDNCT05551780

SponsorSoundBite Medical Solutions, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11

Contact for this trial

John Schultz

514-312-9181 john.schultz@soundbitemedical.com

View on ClinicalTrials.gov More Chronic Total Occlusion of Artery of the Extremities trials