Peripheral Artery Disease
Conditions
Brief summary
The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.
Interventions
DEVICESerranator Sonic Intravascular Lithotripsy (IVL) System
Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.
Sponsors
Cagent Vascular LLC
Clinical Accelerator
Australian Healthcare Solutions
Yale Cardiovascular Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients can have a lesion above the knee treated or up to 2 lesions below the knee treated.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*Inclusion Criteria for Cohort A: ATK arm of the study: Clinical: * Subject is ≥ 18 years of age * Target limb is Rutherford Clinical Category 2, 3 or 4 * Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb Angiographic: * Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery * Reference vessel diameter (RVD) between 4.0 and 8.0mm * Target lesion must have a diameter stenosis of ≥70% * Lesion calcification is at least moderate * Total planned target lesion length must be ≤150mm * Chronic total occlusion lesion length is ≤100mm * Subject has at least one patent tibial vessel on the target limb with runoff to the foot *
Exclusion criteria
for Cohort A: ATK arm of the study: Clinical: * Rutherford Clinical Categories 0, 1, 5 and 6 * Subject with known pregnancy or is nursing * Subject has acute or chronic renal disease, defined as serum creatinine of \>2.5 mg/dL or \>220 µmol/L or on dialysis Angiographic: * Target lesions \>150mm by visual estimation * Chronic total occlusions \> 100mm by visual estimation * No or mild calcium present in the target lesion * Inclusion Criteria for Cohort B: BTK arm of the study: Clinical: * Age of subject is ≥18 * Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection) Angiographic: * Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels * Target vessel reference diameter is between 2.5mm and 4.0 mm * Target lesion with diameter stenosis ≥50% * Target lesion is ≤150mm in length * Subject has at least one patent tibial vessel (\>50%) with run-off to the foot. * Calcification is at least moderate *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Major Adverse Events | 30 Days | Primary Safety: Major Adverse Events (MAE), measured at 30 days and defined as a composite of: * All cardiovascular death * Major amputation * Clinically-driven target lesion revascularization (CD-TLR) |
| Primary Effectiveness: Procedural Success | Procedure | Procedural Success, defined as: \<50% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core-lab assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Major Adverse Events at 6 months | 6 months | Freedom from Major Adverse Events, defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization |
| Freedom from Major Adverse Events at 12 months | 12 months | Freedom from Major Adverse Events defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization. |
| Procedural success of ≤30% residual stenosis of the target lesion | Procedure | Procedural success of ≤30% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core lab assessment |
| Patency rates of target lesion by duplex ultrasound | 30 Days, 6 Months, and 12 Months | Patency rates at 30 days, 6 months, and 12 months of target lesion by duplex ultrasound. Target vessel patency by duplex ultrasound, defined as freedom from \> 50% restenosis, as assessed by duplex ultrasound peak systolic velocity ratio of ≥2.5 |
| Freedom from clinically-driven target lesion revascularization | 30 Days, 6 Months, and 12 Months | Freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days, 6 months, and 12 months |
| Change in Ankle-Brachial Index/Toe-Brachial Index | 30 Days, 6 Months, and 12 Months | Change in Ankle-Brachial Index/Toe-Brachial Index (TBI) at 30 days, 6 months, and 12 months, as compared to baseline |
| Change in Rutherford Category | 30 Days, 6 Months, and 12 Months | Change in Rutherford Category at 30 days, 6 months and 12 months, as compared to baseline |
| Change in Walking Impairment Questionnaire score | 30 Days, 6 Months, and 12 Months | Change in Walking Impairment Questionnaire (WIQ) score at 30 days, 6 months and 12 months, as compared to baseline |
| Change in EuroQol-5D-3L | 30 Days, 6 Months, and 12 Months | Change in EuroQol-5D-3L (EQ-5D-3L) at 30 days, 6 months and 12 months, as compared to baseline |
Contacts
CONTACTAlexis Shewfelt
CONTACTJennifer Meyers Sullivan
Outcome results
None listed