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JAVELIN Study Catheter for Peripheral Arterial Disease (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

FORWARD PAD Trial 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.

Eligible Conditions
  • Peripheral Arterial Disease

FORWARD PAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint - Technical Success
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 days

FORWARD PAD 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
28 Previous Clinical Trials
8,091 Total Patients Enrolled
10 Trials studying Peripheral Arterial Disease
2,216 Patients Enrolled for Peripheral Arterial Disease
~39 spots leftby Jun 2025
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