FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter
(FORWARD PAD Trial)

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Shockwave Medical, Inc.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

You have an estimated life expectancy of over 12 months.

You have Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).

You have one or two native de novo lesions situated in the superficial femoral, popliteal or infrapopliteal artery (above the ankle joint) of either limb.

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Treatment Details

Interventions

Device (Not applicable)

Participant Groups

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.