Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Description

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

Chronic Total Occlusion of Artery of the Extremities

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Study Overview

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Study Details

Study overview

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.

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Condition
Chronic Total Occlusion of Artery of the Extremities
Intervention / Treatment

-

Contacts and Locations

Fort Lauderdale

Palm Vascular Centers, Fort Lauderdale, Florida, United States, 33312

Raleigh

UNC REX Hospial, Raleigh, North Carolina, United States, 27607

Providence

Lifespan - The Miriam Hospital, Providence, Rhode Island, United States, 02906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries:
  • 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
  • 1. Any medical condition that would make subject an inappropriate candidate for interventional treatment as determined by the Investigator, including the following:
  • 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

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SoundBite Medical Solutions, Inc.,

George Adams, MD, PRINCIPAL_INVESTIGATOR, UNC REX Hospital, Raleigh, NC, USA

Michael Lichtenberg, MD, PRINCIPAL_INVESTIGATOR, Angiology Clinic and Vascular Centre, Arnsberg, Germany

Study Record Dates

2024-12