Treatment of Calcific Total Occlusions in Peripheral Artery Disease (CaTO-PAD)

November 29, 2023 updated by: SoundBite Medical Solutions, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SoundBite Crossing System - PAD
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee)
Device: SoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
Experimental: SoundBite Crossing System - BTK
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee)
Device: SoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Performance
Time Frame: Day 0
Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)
Day 0
Device Safety
Time Frame: Day 0
Procedural incidence of any of the following: no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoroscopy Time
Time Frame: Day 0
Day 0
Antegrade Crossing
Time Frame: Day 0
Placement of a guidewire distal to the lesion in the true lumen (Note: retrograde crossing is allowed, but is considered a failure for this endpoint)
Day 0
CTO Crossing Time
Time Frame: Day 0
From first engagement of proximal cap with the Active Wire to guidewire in distal true lumen (or decision made to discontinue attempts)
Day 0
Acute Lumen Gain
Time Frame: Day 0
Difference in final minimal lumen diameter compared to baseline
Day 0
Residual Percent Stenosis
Time Frame: Day 0
Final percent stenosis at procedure end
Day 0
Procedure Time
Time Frame: Day 0
First groin puncture to final sheath removal
Day 0
Number of Devices Used
Time Frame: Day 0
Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents
Day 0
Secondary Safety Endpoint
Time Frame: Day 30 (+10/-0 days)
Rate of 30-day major adverse events (MAE) consisting of: death, emergency surgical revascularization of the target limb, unplanned amputation of the target limb, symptomatic distal thrombus or emboli requiring intervention, perforation requiring treatment
Day 30 (+10/-0 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SoundBite Medical Solutions, Inc.

Investigators

  • Principal Investigator: George Adams, MD, UNC REX Hospital, Raleigh, NC, USA
  • Principal Investigator: Michael Lichtenberg, MD, 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 Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT-PER-2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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