Treatment of Calcific Total Occlusions in Peripheral Artery Disease
NCT ID: NCT05551780
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2023-02-21
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SoundBite Crossing System - PAD
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee)
SoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
SoundBite Crossing System - BTK
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee)
SoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
Interventions
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SoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
Eligibility Criteria
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Inclusion Criteria
1. CaTO-PAD: infrainguinal
2. CaTO-BTK: infrapopliteal
2. Have at least one chronic total occlusion (CTO) with no flow observed in the distal lesion except the flow from collateral circulation
3. Presenting with the following:
1. CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb
2. 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
4. Age of \> 18 years
5. Have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form
6. Target lesion calcification is at least moderate by PARC definition (see Section 15)
7. Target lesion is refractory as demonstrated by a failed attempt with a guidewire
Exclusion Criteria
1. Glomerular filtration rate \<30 ml/min
2. Mortality expected within 30 days
2. Already enrolled in an investigational interventional study that would interfere with study endpoints
3. Target lesion is crossed intraluminally with a conventional guidewire
4. 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
5. Women who are pregnant or breastfeeding
19 Years
ALL
No
Sponsors
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SoundBite Medical Solutions, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George Adams, MD
Role: PRINCIPAL_INVESTIGATOR
UNC REX Hospital, Raleigh, NC, USA
Michael Lichtenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Angiology Clinic and Vascular Centre, Arnsberg, Germany
Locations
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Palm Vascular Centers
Fort Lauderdale, Florida, United States
UNC REX Hospial
Raleigh, North Carolina, United States
Lifespan - The Miriam Hospital
Providence, Rhode Island, United States
Medizinische Universität Graz
Graz, , Austria
Angiology Clinic and Vascular Centre
Arnsberg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INT-PER-2022-01
Identifier Type: -
Identifier Source: org_study_id
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