RECRUITING

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Conditions

Chronic Total Occlusion of Artery of the Extremities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Quick Facts

Study Start:2023-02-21

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05551780

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.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

John Schultz

CONTACT

514-312-9181

john.schultz@soundbitemedical.com

Principal Investigator

George Adams, MD

PRINCIPAL_INVESTIGATOR

UNC REX Hospital, Raleigh, NC, USA

Michael Lichtenberg, MD

PRINCIPAL_INVESTIGATOR

Angiology Clinic and Vascular Centre, Arnsberg, Germany

Study Locations (Sites)

Palm Vascular Centers

Fort Lauderdale, Florida, 33312

United States

UNC REX Hospial

Raleigh, North Carolina, 27607

United States

Lifespan - The Miriam Hospital

Providence, Rhode Island, 02906

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-21

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-02-21

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Chronic Total Occlusion of Artery of the Extremities