FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Registration Number: NCT05858905

Lead Sponsor: Shockwave Medical, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days	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)
Primary Effectiveness Endpoint - Technical Success	Peri-Procedural, immediately after all therapy of the target lesion was completed.	Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.

Secondary Outcome Measures

Name	Time	Method
Serious Angiographic Complications	Peri-Procedural	Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory
IVL Technical Success (Post- Dilatation)	Peri-Procedural	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).
IVL Device Success	Peri-Procedural	Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter.
Technical Success (Final)	Peri-Procedural	Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory
MAEs at 6-months Post Procedure	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)
MAEs at 12-months Post Procedure	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)
Primary Patency at 12-Months	12-Months Post Procedure	* 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

Trial Locations

Locations (21): Stanford Hospital and Clinics (SHC)
🇺🇸
Palo Alto, California, United States
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
Scroll for more (11 remaining)
Stanford Hospital and Clinics (SHC)
🇺🇸Palo Alto, California, United States