Chronic Total Occlusion of Artery of the Extremities
Conditions
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)
Interventions
DEVICESoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
Sponsors
SoundBite Medical Solutions, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Time | Day 0 | — |
| Number of Devices Used | Day 0 | Conventional guidewires, microcatheters, atherectomy devices, re-entry devices, balloons, stents |
| 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) |
| Residual Percent Stenosis | Day 0 | Final percent stenosis at procedure end |
| Acute Lumen Gain | Day 0 | Difference in final minimal lumen diameter compared to baseline |
| 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 |
| 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) |
| Procedure Time | Day 0 | First groin puncture to final sheath removal |
Countries
Austria, Germany, United States
Contacts
Primary ContactJohn Schultz
Outcome results
None listed