Chronic Total Occlusion of Artery of the ExtremitiesCaTO-PADNCT05551780
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
A study testing SoundBite Crossing System in people with Chronic Total Occlusion of Artery of the Extremities, run by SoundBite Medical Solutions, Inc. at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Total Occlusion of Artery of the Extremities
- What is being tested?
- SoundBite Crossing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 21 Feb 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites, 3 recruiting
- Recruiting
Palm Vascular Centers
Fort Lauderdale, Florida, 33312
Jennifer Gimeno, Jennifer@palmvascular.com
- Recruiting
Lifespan - The Miriam Hospital
Providence, Rhode Island, 02906
Lina Felix, lfelix@lifespan.org
- Not yet recruiting
UNC REX Hospial
Raleigh, North Carolina, 27607
Rebecca Palermo, Rebecca.Palermo@unchealth.unc.edu
Austria1 site, 1 recruiting
- Not yet recruiting
Medizinische Universität Graz
Graz
Romana Schuh, romana.schuh@medunigraz.at
Germany1 site, 1 recruiting
- Not yet recruiting
Angiology Clinic and Vascular Centre
Arnsberg
Simone Müller, S.Mueller@klinikum-hochsauerland.de
About this study
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.
Read the detailed description
The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)
- Being tested
- SoundBite Crossing System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoundBite Crossing SystemDevice
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
| Study group | Role | What they receive |
|---|---|---|
| SoundBite Crossing System - PAD | Experimental | Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee) Receives: Device: SoundBite Crossing System |
| SoundBite Crossing System - BTK | Experimental | Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee) Receives: Device: SoundBite Crossing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Performance
Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)
Measured: Day 0
Device Safety
Procedural incidence of any of the following: no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment
Measured: Day 0
Secondary outcomes (8)
Antegrade Crossing
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)
Measured: Day 0
CTO Crossing Time
From first engagement of proximal cap with the Active Wire to guidewire in distal true lumen (or decision made to discontinue attempts)
Measured: Day 0
Acute Lumen Gain
Difference in final minimal lumen diameter compared to baseline
Measured: Day 0
Residual Percent Stenosis
Final percent stenosis at procedure end
Measured: Day 0
Procedure Time
First groin puncture to final sheath removal
Measured: Day 0
Fluoroscopy Time
Measured: Day 0
Number of Devices Used
Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents
Measured: Day 0
Secondary Safety Endpoint
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
Measured: Day 30 (+10/-0 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start21 Feb 2023
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Artery of the ExtremitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoundBite Medical Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Adams, MD, Principal investigator, UNC REX Hospital, Raleigh, NC, USAMichael Lichtenberg, MD, Principal investigator, Angiology Clinic and Vascular Centre, Arnsberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551780
- Sponsor's protocol ID
- INT-PER-2022-01
- Acronym
- CaTO-PAD
- Status last verified
- Jun 2024
- First submitted
- 14 Sep 2022
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Calcific Total Occlusions in Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT05551780
- Acronym / sponsor ID
- CaTO-PAD / INT-PER-2022-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- SoundBite Medical Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoundBite Crossing System - PAD | Experimental | Device: SoundBite Crossing SystemUse of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee) |
| SoundBite Crossing System - BTK | Experimental | Device: SoundBite Crossing SystemUse of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries:
- 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:
- Age of > 18 years
- Have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form
Key exclusion criteria (7 listed)
- Any medical condition that would make subject an inappropriate candidate for interventional treatment as determined by the Investigator, including the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoundBite Crossing SystemUse of the SoundBite Crossing System to cross calcified chronic total occlusions | Device | SoundBite Crossing System - BTK, SoundBite Crossing System - PAD |
Primary outcome
Device Performance
Time frame: Day 0
Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)
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
8 secondary outcomes
Antegrade Crossing
Time frame: Day 0
CTO Crossing Time
Time frame: Day 0
Acute Lumen Gain
Time frame: Day 0
Residual Percent Stenosis
Time frame: Day 0
Procedure Time
Time frame: Day 0
Fluoroscopy Time
Time frame: Day 0
Number of Devices Used
Time frame: Day 0
Secondary Safety Endpoint
Time frame: Day 30 (+10/-0 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Adams, MD principal investigator
UNC REX Hospital, Raleigh, NC, USA
Michael Lichtenberg, MD principal investigator
Angiology Clinic and Vascular Centre, Arnsberg, Germany
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SoundBite Crossing System in people with Chronic Total Occlusion of Artery of the Extremities, run by SoundBite Medical Solutions, Inc. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Schultz (514-312-9181, john.schultz@soundbitemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Performance (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.