FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Intravascular Lithotripsy
- 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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JAVELIN Study Catheter Intravascular Lithotripsy The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
- 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 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
Trial Locations
- Locations (21)
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
Marshfield Medical Center
🇺🇸Marshfield, Wisconsin, 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
Ascension Columbia St. Mary's
🇺🇸Milwaukee, Wisconsin, United States
Stanford Hospital and Clinics (SHC)
🇺🇸Palo Alto, California, United States
Advanced Heart and Vein Center
🇺🇸Thornton, Colorado, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
NYU Langone Health
🇺🇸New York, New York, United States
Charlotte Radiology
🇺🇸Charlotte, North Carolina, United States
The Lindner Research Center at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Ascension St. John Jane Phillips Hosptial
🇺🇸Bartlesville, Oklahoma, United States
Lankenau Institute for Medical Research
🇺🇸Bryn Mawr, Pennsylvania, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Heart Hospital Baylor
🇺🇸Plano, Texas, United States