Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Status unconfirmed · Not applicable

Conditions studied: Chronic Total Occlusion of Artery of the Extremities

In brief

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.

Key facts

Study ID: NCT05551780
Run by: SoundBite Medical Solutions, Inc.
People needed: 130
Starts: 2023-02-21
Expected to finish: 2024-12-01
Last updated by the study team: 2024-06-13

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Palm Vascular Centers — Fort Lauderdale, Florida, United States (enrolling)
Lifespan - The Miriam Hospital — Providence, Rhode Island, United States (enrolling)
UNC REX Hospial — Raleigh, North Carolina, United States
Medizinische Universität Graz — Graz, Austria
Angiology Clinic and Vascular Centre — Arnsberg, Germany

Full record on ClinicalTrials.gov

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