NCT05551780

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
3 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1.7 years

First QC Date

September 14, 2022

Last Update Submit

June 12, 2024

Conditions

Chronic Total Occlusion of Artery of the Extremities

Outcome Measures

Primary Outcomes (2)

  • Device Performance

    Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)

    Day 0

  • Device Safety

    Procedural incidence of any of the following: no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment

    Day 0

Secondary Outcomes (8)

  • Antegrade Crossing

    Day 0

  • CTO Crossing Time

    Day 0

  • Acute Lumen Gain

    Day 0

  • Residual Percent Stenosis

    Day 0

  • Procedure Time

    Day 0

  • +3 more secondary outcomes

Study Arms (2)

SoundBite Crossing System - PAD

EXPERIMENTAL

Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee)

Device: SoundBite Crossing System

SoundBite Crossing System - BTK

EXPERIMENTAL

Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee)

Device: SoundBite Crossing System

Interventions

SoundBite Crossing SystemDEVICE

Use of the SoundBite Crossing System to cross calcified chronic total occlusions

SoundBite Crossing System - BTKSoundBite Crossing System - PAD

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Palm Vascular Centers

Fort Lauderdale, Florida, 33312, United States

RECRUITING

UNC REX Hospial

Raleigh, North Carolina, 27607, United States

NOT YET RECRUITING

Lifespan - The Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Medizinische Universität Graz

Graz, Austria

NOT YET RECRUITING

Angiology Clinic and Vascular Centre

Arnsberg, Germany

NOT YET RECRUITING

Study Officials

  • George Adams, MD

    UNC REX Hospital, Raleigh, NC, USA

    PRINCIPAL INVESTIGATOR

  • Michael Lichtenberg, MD

    Angiology Clinic and Vascular Centre, Arnsberg, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Schultz

CONTACT

514-312-9181john.schultz@soundbitemedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 23, 2022

Study Start

February 21, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)DE(1)AU(1)