CaTO-BTK: Treatment of Calcific Total Occlusions Below-The-Knee

• Sponsor: SoundBite Medical Solutions, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05551780
• Collaborator: (none)
• Enrollment: 110
• Locations: 5
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site: 22
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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-Peripheral (SCS-P).

Condition or Disease	Intervention/Treatment	Phase
Chronic Total Occlusion of Artery of the Extremities	Device: SoundBite Crossing System-Peripheral	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Calcific Total Occlusions Below-The-Knee
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SoundBite Crossing System-Peripheral Use of the SoundBite Crossing System-Peripheral to cross calcified chronic total occlusions below-the-knee	Device: SoundBite Crossing System-Peripheral; Use of the SoundBite Crossing System-Peripheral to cross calcified chronic total occlusions below-the-knee.

Outcome Measures

Primary Outcome Measures

1. Device Performance [Day 0]

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

2. Device Safety [Day 0]

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

Secondary Outcome Measures

1. Antegrade Crossing [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)

2. CTO Crossing Time [Day 0]

   From first engagement of proximal cap with the Active Wire to guidewire in distal true lumen (or decision made to discontinue attempts)

3. Acute Lumen Gain [Day 0]

   Difference in final minimal lumen diameter compared to baseline

4. Residual Percent Stenosis [Day 0]

   Final percent stenosis at procedure end

5. Procedure Time [Day 0]

   First groin puncture to final sheath removal

6. Fluoroscopy Time [Day 0]

7. Number of Devices Used [Day 0]

   Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents

8. Secondary Safety Endpoint [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Scheduled for interventional treatment of de-novo lesion(s) of native infrapopliteal arteries

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 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:

2. Glomerular filtration rate <30 ml/min

3. Mortality expected within 30 days

4. Already enrolled in an investigational interventional study that would interfere with study endpoints

5. Target lesion is crossed intraluminally with a conventional guidewire

6. 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

7. Women who are pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palm Vascular Centers	Fort Lauderdale	Florida	United States	33312
2	UNC REX Hospial	Raleigh	North Carolina	United States	27607
3	Lifespan - The Miriam Hospital	Providence	Rhode Island	United States	02906
4	Medizinische Universität Graz	Graz		Austria
5	Angiology Clinic and Vascular Centre	Arnsberg		Germany

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SoundBite Medical Solutions, Inc.
• ClinicalTrials.gov Identifier: NCT05551780
• Other Study ID Numbers: INT-PER-2022-01
• First Posted: Sep 23, 2022
• Last Update Posted: Sep 23, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Sep 23, 2022