Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457685
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Amplitude Vascular Systems AVS Lithotripsy POWER PAD 2 Trial
Sponsor:
Amplitude Vascular Systems Inc
Organization:
Amplitude Vascular Systems Inc
Study Overview
Official Title:
Pulse Intravascular Lithotripsy Pulse IVL to Open Vessels with Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POWER PAD 2
Brief Summary:
POWER PAD 2 is a prospective single-arm multicenter non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems AVS Pulse Intravascular Lithotripsy Pulse IVL System for treatment of calcified moderate to severe stenotic superficial femoral and popliteal arteries in patients with peripheral arterial disease
Detailed Description:
POWER PAD 2 is a prospective single-arm multicenter non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular System AVS Pulse Intravascular Lithotripsy Pulse IVL System for treatment of calcified moderate to severe stenotic superficial femoral and popliteal arteries in patients with peripheral arterial disease This study will enroll subjects 18 years old that are presenting for a peripheral arterial disease intervention for the treatment of peripheral artery disease Specifically the subject has moderate to heavily calcified superficial femoral and popliteal arteries presenting with Rutherford Category 2 to 4 of the target limb with a reference vessel diameter RVD of 4mm to 65mm and a total lesion length of 150mm Up to 120 subjects will be treated in the study at up to 20 US investigational sites Subjects will be evaluated at discharge 30 days and 6 months after procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None