Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Not Applicable

Recruiting

• Conditions: Chronic Total Occlusion of Artery of the Extremities

• Registration Number: NCT05551780
• Lead Sponsor: SoundBite Medical Solutions, Inc.

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-23
• Study Start: 2023-02-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Device Performance	Day 0	Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)
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

Name	Time	Method
Residual Percent Stenosis	Day 0	Final percent stenosis at procedure end
Number of Devices Used	Day 0	Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents
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)
Fluoroscopy Time	Day 0
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
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)
Procedure Time	Day 0	First groin puncture to final sheath removal
Acute Lumen Gain	Day 0	Difference in final minimal lumen diameter compared to baseline

Trial Locations

Locations (5)

Palm Vascular Centers; 🇺🇸 Fort Lauderdale, Florida, United States

UNC REX Hospial; 🇺🇸 Raleigh, North Carolina, United States

Lifespan - The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Angiology Clinic and Vascular Centre; 🇩🇪 Arnsberg, Germany