Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Chronic Total Occlusion of Artery of the Extremities Clinical Trial

— CaTO-PAD  

Official title:

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551780
• Other study ID #: INT-PER-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: SoundBite Medical Solutions, Inc.
• Contact: John Schultz
• Phone: 514-312-9181
• Email: john.schultz[@]soundbitemedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Total Occlusion of Artery of the Extremities
• Peripheral Arterial Disease

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Germany	Angiology Clinic and Vascular Centre	Arnsberg
United States	Palm Vascular Centers	Fort Lauderdale	Florida
United States	Lifespan - The Miriam Hospital	Providence	Rhode Island
United States	UNC REX Hospial	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
SoundBite Medical Solutions, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Performance	Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)	Day 0
Primary	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	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)	Day 0
Secondary	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)	Day 0
Secondary	Acute Lumen Gain	Difference in final minimal lumen diameter compared to baseline	Day 0
Secondary	Residual Percent Stenosis	Final percent stenosis at procedure end	Day 0
Secondary	Procedure Time	First groin puncture to final sheath removal	Day 0
Secondary	Fluoroscopy Time		Day 0
Secondary	Number of Devices Used	Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents	Day 0
Secondary	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	Day 30 (+10/-0 days)