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Not applicable
FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter (FORWARD PAD Trial)
N/A
Waitlist Available
Research Sponsored by Shockwave Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up peri-procedural
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device that uses sound waves to break up hard calcium deposits in the leg arteries. It targets patients with severe artery blockages that are hard to treat with usual methods. The goal is to see if this device is safe and effective for these patients.
Eligible Conditions
- Peripheral Artery Disease
- Peripheral Arterial Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Effectiveness Endpoint - Technical Success
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 days
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: JAVELIN Study CatheterExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Shockwave Medical, Inc.Lead Sponsor
31 Previous Clinical Trials
9,442 Total Patients Enrolled