Critical Limb Ischemia
Conditions
Brief summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Interventions
DEVICESerranator PTA Serration Catheter
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
Sponsors
Cagent Vascular LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rutherford clinical category 4-6 of the target limb * Age of subjects is \>18 years old * Patients has given informed consent to participate in this study
Exclusion criteria
* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion * Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries. * Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm. * Lesion length less than 220 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Lumen Volume Stenosis | Baseline | Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiography Residual Diameter Stenosis | Baseline | Residual stenosis as measured by angiography |
| Dissection Pattern | Baseline | The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration. |
| OCT Residual Diameter Stenosis | Baseline | Residual stenosis as measured by OCT |
| Rate of Optimal PTA | Baseline | Rate of procedures that achieve optimal PTA (\<30% diameter stenosis without flow-limiting dissection measured by angiography) |
| Bail-out Stenting | Baseline | Rate of bail-out stenting |
| Correlation of Luminal Gain and Plaque Modification | Baseline | The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab. |
Countries
United States
Contacts
Primary ContactFeeny
Backup ContactWittwer
Outcome results
None listed