FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter

(FORWARD PAD Trial)

Recruiting at 21 trial locations

Overseen By Bhavana Shivakumar

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Shockwave Medical, Inc.

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Recent stroke, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Peri-Procedural

75 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antiplatelet or anticoagulant therapy, you should not participate if these are contraindicated (not advised for your condition). It's best to discuss your current medications with the trial team.

How is the Aortix System treatment different from other treatments for aortic valve conditions?

The Aortix System is unique because it is an endovascular device, meaning it is placed inside the blood vessels, which can offer a less invasive alternative to traditional surgical aortic valve replacement. Unlike some other treatments, it may not require the removal of the native valve, potentially reducing the complexity and risks associated with surgery. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Shockwave Medical Mini S Peripheral IVL System for heavily calcified, stenotic peripheral arteries

Peri-Procedural

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for Major Adverse Events (MAE) at 30 days

30 days

Treatment Details

Interventions

• Device

Participant Groups

Group I: JAVELIN Study Catheter Experimental Treatment 1 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.

Device is already approved in United States for the following indications:

Approved in United States as Aortix System for:

• None - Investigational use only

Who Is Running the Clinical Trial?

Shockwave Medical, Inc.

Lead Sponsor

Trials

38

Recruited

10,200+

References

1. England pubmed.ncbi.nlm.nih.gov

The aortic root: simple as possible, but not simpler. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Delayed dislocation of a sutureless aortic bioprosthesis: the first case. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The third hand--a simple but useful tool for holding the sheath during transapical transcatheter aortic valve implantation. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Intra-operative 2-D ultrasound and dynamic 3-D aortic model registration for magnetic navigation of transcatheter aortic valve implantation. [2013]