RecruitingNot ApplicableNCT05551780
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
Sponsor
SoundBite Medical Solutions, Inc.
Enrollment
130 participants
Start Date
Feb 21, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 19 Years
Inclusion Criteria11
- 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 Criteria7
- 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
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Interventions
DEVICESoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05551780