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

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 Arterial Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

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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