Actively Recruiting
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
Led by SoundBite Medical Solutions, Inc. · Updated on 2024-06-13
130
Participants Needed
5
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for interventional treatment of de-novo lesion(s) in native arteries below the groin or below the knee
- Have at least one chronic total occlusion with no blood flow beyond the blockage except from collateral circulation
- Present claudication or critical limb ischemia (Rutherford Clinical Category 2-5) in the target limb
- Be 18 years of age or older
- Have been informed about the study, agree to participate, and have signed the consent form
- Have target lesion calcification at least moderate by PARC definition
- Have target lesion refractory to treatment as shown by a failed guidewire attempt
You will not qualify if you...
- Have any medical condition making you unsuitable for interventional treatment, including glomerular filtration rate less than 30 ml/min or expected mortality within 30 days
- Currently enrolled in another investigational interventional study that would interfere with study endpoints
- Target lesion already crossed intraluminally with a conventional guidewire
- Treatment of an inflow lesion before target lesion treatment causes no blood flow, thrombus, abrupt closure, distal embolization, dissection, or perforation needing treatment
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Palm Vascular Centers
Fort Lauderdale, Florida, United States, 33312
Actively Recruiting
2
UNC REX Hospial
Raleigh, North Carolina, United States, 27607
Not Yet Recruiting
3
Lifespan - The Miriam Hospital
Providence, Rhode Island, United States, 02906
Actively Recruiting
4
Medizinische Universität Graz
Graz, Austria
Not Yet Recruiting
5
Angiology Clinic and Vascular Centre
Arnsberg, Germany
Not Yet Recruiting
Research Team
J
John Schultz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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