Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
35
The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
Sir Charles Gairdner Hospital
Nedlands, Perth, Australia
Royal Perth Hospital
Perth, Australia
Auckland City Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Primary Safety: Major Adverse Events (MAE)
Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular Death * Clinically Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
Time frame: 30 days
Primary Performance: Technical Success
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab
Time frame: Peri-Procedural
Serious Angiographic Complications
Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory.
Time frame: Peri-Procedural
IVL Technical Success (Post- Dilatation)
Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
Time frame: Peri-Procedural
IVL Device Success
Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter
Time frame: Peri-Procedural
Technical Success (Final)
Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory
Time frame: Peri-Procedural
Major Adverse Events (MAEs) at 6-months Post Procedure
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Major Adverse Events (MAEs) at 6 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
Time frame: 6 Months Post-Procedure
MAEs at 12-months Post Procedure
Major Adverse Events (MAEs) at 12 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
Time frame: 12 Months Post-Procedure
Primary Patency at 12 Months
Primary patency for Above-the-Knee (ATK) lesions is defined as freedom from ≥50% restenosis as determined by DUS and freedom from CD-TLR at 12 months post-procedure. Primary patency for Below-the-Knee (BTK) lesions is defined as freedom from total occlusion (100% diameter stenosis by DUS) in all target lesions within a flow pathway and freedom from CD-TLR at 12 months post-procedure.
Time frame: 12 Months post-procedure