Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Launched by SOUNDBITE MEDICAL SOLUTIONS, INC. · Sep 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with a condition called chronic total occlusion (CTO) in the arteries of the legs. CTO means that one or more arteries are completely blocked, which can cause pain or other serious issues in the legs. The study is specifically looking at a device called the SoundBite Crossing System XS Peripheral, which aims to help doctors safely and effectively open these blocked arteries. It is currently open for recruitment and welcomes participants aged 18 and older, who are scheduled for treatment of their artery blockage and have not had successful attempts to clear the blockage previously.

To be eligible for the trial, participants need to have at least one chronic total occlusion in the arteries of their legs and experience symptoms like leg pain during walking (called claudication) or more severe issues. Participants should be able to understand the study and agree to take part by signing a consent form. Throughout the trial, participants will receive the new treatment and will be monitored for safety and effectiveness. It's important to note that certain medical conditions might prevent someone from joining, such as severe kidney problems or being pregnant. Overall, this trial hopes to provide valuable information about a new approach to treating a challenging condition in patients with peripheral artery disease.

Gender

ALL

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