Clinical trial NCT05551780: Treatment of Calcific Total Occlusions in Peripheral Artery Disease
Official title: Treatment of Calcific Total Occlusions in Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Total Occlusion of Artery of the Extremities
Lead sponsor: SoundBite Medical Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Device Performance
timeFrame: Day 0
measure: Device Safety
timeFrame: Day 0
Secondary outcomes:
measure: Antegrade Crossing
timeFrame: Day 0
measure: CTO Crossing Time
timeFrame: Day 0
measure: Acute Lumen Gain
timeFrame: Day 0
measure: Residual Percent Stenosis
timeFrame: Day 0
measure: Procedure Time
timeFrame: Day 0
measure: Fluoroscopy Time
timeFrame: Day 0
measure: Number of Devices Used
timeFrame: Day 0
measure: Secondary Safety Endpoint
timeFrame: Day 30 (+10/-0 days)
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Palm Vascular Centers
state: Florida
city: Raleigh
country: United States
facility: UNC REX Hospial
state: North Carolina
city: Providence
country: United States
facility: Lifespan - The Miriam Hospital
state: Rhode Island
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Arnsberg
country: Germany
facility: Angiology Clinic and Vascular Centre
Study officials:
affiliation: UNC REX Hospital, Raleigh, NC, USA
name: George Adams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Angiology Clinic and Vascular Centre, Arnsberg, Germany
name: Michael Lichtenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: