Treatment for blocked arteries in patients with peripheral artery disease

Treatment of Calcific Total Occlusions in Peripheral Artery Disease

This study is testing a new device to see if it can safely help people with blocked arteries due to peripheral artery disease feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: SoundBite Medical Solutions, Inc. (Industry-sponsored)
• Locations: 5 sites (Fort Lauderdale, Florida and 4 other locations)
• Trial ID: NCT05551780 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and performance of the SoundBite Crossing System XS Peripheral in treating chronic total occlusions (CTOs) in patients with peripheral artery disease. It is a prospective, multi-center, non-randomized, open-label study that includes a sub-study focused on below-the-knee occlusions. Participants will undergo interventional treatment for de-novo lesions in specific native arteries, with eligibility based on the presence of CTOs and associated symptoms. The study aims to gather data that could support the effectiveness of this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with chronic total occlusions in their arteries, experiencing claudication or critical limb ischemia.

Not a fit: Patients with medical conditions that would make them inappropriate for the intervention or those without significant arterial blockage may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow and alleviate symptoms for patients suffering from chronic total occlusions.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating peripheral artery disease, suggesting potential for success.

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

Where this trial is running

Fort Lauderdale, Florida and 4 other locations

• Palm Vascular Centers — Fort Lauderdale, Florida, United States (Recruiting)
• UNC REX Hospial — Raleigh, North Carolina, United States (Not_yet_recruiting)
• Lifespan - The Miriam Hospital — Providence, Rhode Island, United States (Recruiting)
• Medizinische Universität Graz — Graz, Austria (Not_yet_recruiting)
• Angiology Clinic and Vascular Centre — Arnsberg, Germany (Not_yet_recruiting)

Study contacts

• Principal investigator: George Adams, MD — UNC REX Hospital, Raleigh, NC, USA
• Study coordinator: John Schultz

Conditions Chronic Total Occlusion of Artery of the Extremities