Chronic Total Occlusion of Artery of the Extremities, Peripheral Arterial Occlusive Disease
Conditions
Keywords
Chronic Total Occlusion, CTO, Crossing Device, Peripheral, SoundBite Crossing System
Brief summary
This study aims at assessing additional performance characteristics of the SoundBite™ Crossing System with regards to the luminal passage of complex Chronic Total Occlusions (CTO) by evaluating clinically relevant efficacy, safety, cost benefit and treatment pathway endpoints.
Detailed description
This multinational study will be based on observational cases with descriptive statistics to collect data on safety and efficacy based on clinical use of the SoundBite™ Crossing System. This study will include a cost benefit analysis that will focus on wire and other Percutaneous Transluminal Angioplasty (PTA) device usage during the procedure. The cost benefit will be compared to the sites data on their average costs for CTO crossing cases. The planned treatment pathway elected prior to procedure will be compared to subject's treatment pathway plan post -procedure (discharge, surgeries such as bypass, amputation etc.) will be collected to determine patient outcomes.
Interventions
SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.
Sponsors
ethica Clinical Research Inc.
Montreal Heart Institute
SoundBite Medical Solutions, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The population includes subjects with documented symptomatic peripheral CTOs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria * Has symptomatic non-acute limb ischemia, requiring treatment of an infrainguinal artery * Has Rutherford Clinical Category of 2-6 * is able and willing to provide written informed consent prior to study procedure Angiographic Inclusion Criteria * 100% stenosis by a visual estimate of angiography at the time of the procedure * target CTO has moderate to severe calcification * Has at least one of the following: severe calcification, flush occlusion, femoropopliteal CTOs with reconstitution below Popliteal 2-3, side directing collateral at the proximal cap, long (≥ 5cm) occlusions, below the knee (BTK) occlusion. * Has evidence of a clinically significant CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of the procedure.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful CTO Crossing assessed by angiographic imaging | at time of procedure | Successful CTO Crossing using the SoundBite™ Crossing System (SCS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful luminal CTO crossing using the SCS with or without imaging assistance. | at time of procedure | Luminal crossing defined as ≥50% true lumen passage as assessed by an independent imaging core lab. |
| Costs benefits associated with the use of the SCS compared to a retrospective randomly selected chart review of conventional PTA wire escalation at the clinical site. | through study completion; 15 months | Imaging costs are excluded |
| Freedom from SCS related Major Adverse Events (MAE) at the time of procedure/discharge | at procedure until discharge; up to 48 hours | MAEs examples: unplanned, index limb amputation, dissection of grade C or greater that require an intervention to resolve |
Countries
Austria, Germany
Outcome results
None listed