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| Name | Class |
|---|---|
| Clinical Accelerator | INDUSTRY |
| Australian Healthcare Solutions | UNKNOWN |
| Yale Cardiovascular Research Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Above-the-Knee | Experimental | For blockages in the legs that occur above the knee. |
|
| Below-the-Knee | Experimental | For blockages in the legs that occur below the knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serranator Sonic Intravascular Lithotripsy (IVL) System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety: Major Adverse Events | Primary Safety: Major Adverse Events (MAE), measured at 30 days and defined as a composite of:
| 30 Days |
| Primary Effectiveness: Procedural Success | 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 | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Major Adverse Events at 6 months | Freedom from Major Adverse Events, defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization | 6 months |
| Freedom from Major Adverse Events at 12 months |
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*Inclusion Criteria for Cohort A: ATK arm of the study:
Clinical:
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
Clinical:
Angiographic:
Target lesions >150mm by visual estimation
Chronic total occlusions > 100mm by visual estimation
No or mild calcium present in the target lesion
Clinical:
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
Clinical:
Angiographic:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexis Shewfelt | Contact | 650-208-6743 | ashewfelt33@cagentvascular.com | |
| Jennifer Meyers Sullivan | Contact | 219-730-9402 | jsullivan64@cagentvascular.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Patients can have a lesion above the knee treated or up to 2 lesions below the knee treated.
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|
Freedom from Major Adverse Events defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization. |
| 12 months |
| Procedural success of ≤30% residual stenosis of the target lesion | Procedural success of ≤30% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core lab assessment | Procedure |
| Patency rates of target lesion by duplex ultrasound | 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 | 30 Days, 6 Months, and 12 Months |
| Freedom from clinically-driven target lesion revascularization | Freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days, 6 months, and 12 months | 30 Days, 6 Months, and 12 Months |
| Change in Ankle-Brachial Index/Toe-Brachial Index | Change in Ankle-Brachial Index/Toe-Brachial Index (TBI) at 30 days, 6 months, and 12 months, as compared to baseline | 30 Days, 6 Months, and 12 Months |
| Change in Rutherford Category | Change in Rutherford Category at 30 days, 6 months and 12 months, as compared to baseline | 30 Days, 6 Months, and 12 Months |
| Change in Walking Impairment Questionnaire score | Change in Walking Impairment Questionnaire (WIQ) score at 30 days, 6 months and 12 months, as compared to baseline | 30 Days, 6 Months, and 12 Months |
| Change in EuroQol-5D-3L | Change in EuroQol-5D-3L (EQ-5D-3L) at 30 days, 6 months and 12 months, as compared to baseline | 30 Days, 6 Months, and 12 Months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |