The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
Stanford Hospital and Clinics (SHC)
Palo Alto, California, United States
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days
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 Effectiveness Endpoint - Technical Success
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.
Time frame: Peri-Procedural, immediately after all therapy of the target lesion was completed.
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, as 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Advanced Heart and Vein Center
Thornton, Colorado, United States
HCA Florida Blake Hospital
Bradenton, Florida, United States
Tallahassee Memorial Healthcare, Inc.
Tallahassee, Florida, United States
UnityPoint Health Trinity Bettendorf Hospital
Bettendorf, Iowa, United States
Cardiovascular Medicine PC
Davenport, Iowa, United States
MedStar Montgomery Medical Center
Olney, Maryland, United States
Southcoast Hospitals Group
New Bedford, Massachusetts, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
NYU Langone Health
New York, New York, United States
...and 11 more locations
MAEs at 6-months Post Procedure
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
* Above the knee lesions: freedom from ≥50% restenosis as determined by Duplex Ultrasound (DUS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR) * Below the knee lesions: freedom from both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a CD-TLR
Time frame: 12-Months Post Procedure