Intravascular Lithotripsy for Peripheral Artery Disease

(FORWARD PAD Trial)

No longer recruiting at 21 trial locations

Overseen By Bhavana Shivakumar

Age: 18+

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device, the Shockwave Medical Mini S Peripheral IVL System, to determine if it safely and effectively treats blocked or narrowed peripheral arteries with significant calcium buildup. It targets individuals with moderate to severe peripheral artery disease (PAD), which affects leg arteries and can cause pain or difficulty walking. Those with PAD and blockages in the leg arteries who have not had recent leg surgeries might be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment options for PAD.

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.

What prior data suggests that the Shockwave Medical Mini S Peripheral IVL System is safe for treating heavily calcified, stenotic peripheral arteries?

Research shows that the Shockwave Medical Mini S Peripheral IVL System treats severely narrowed leg arteries by breaking up calcium deposits with sound waves. Although this might sound intense, it is a well-studied method.

The study phase is listed as "Not Applicable," likely indicating that earlier research has already demonstrated the device's safety. However, no specific data sources confirm this. Generally, devices at this stage have undergone human testing and are considered safe enough for further study.

For those considering joining a trial for this device, it's important to know that similar devices are usually well-tolerated, but individual experiences can vary. Always consult a healthcare provider to understand what this could mean for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Shockwave Javelin IVL Catheter is unique because it uses a novel intravascular lithotripsy (IVL) technique to treat peripheral artery disease (PAD), particularly in arteries with heavy calcification. Unlike traditional treatments like balloon angioplasty or stenting, which can struggle with severely calcified lesions, the Javelin catheter uses sonic pressure waves to safely fracture calcium deposits in the arteries. This approach potentially allows for more effective artery dilation with less risk of damage to the vessel wall, making it an exciting development for improving outcomes in patients with challenging PAD cases.

What evidence suggests that the Shockwave Medical Mini S Peripheral IVL System is effective for treating heavily calcified, stenotic peripheral arteries?

This trial will evaluate the JAVELIN Study Catheter for treating subjects with moderate to severely calcified peripheral artery disease (PAD). Research has shown that devices like the Shockwave Medical Mini S Peripheral IVL System, designed to treat severely narrowed arteries in the legs with significant calcium buildup, can break up calcium and improve blood flow. These systems use sound waves to target and crack calcium deposits, making it easier for doctors to open arteries and restore blood flow. Early results from other studies on similar devices showed better outcomes for patients with difficult artery blockages. These findings suggest that treatments like the JAVELIN Study Catheter could be effective for people with severe peripheral artery disease. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Device

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04145635

Study Details | NCT04145635 | The Aortix CRS Pilot Study The study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and performance of the Aortix System in patients ...

2. mountsinai.org mountsinai.org/clinical-trials/diuretics-alone-vs-aortix-endovascular-device-for-acute-heart-failure

Diuretics Alone vs. Aortix Endovascular Device for Acute ... Summary: Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4504240/

Endovascular Intervention for Peripheral Artery Disease Subgroup analysis showed that treatment with DES was associated with superior outcomes for complex disease, including total occlusions and longer lesions (>70 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509625006235

Peripheral Artery Disease Diagnosis Is an Independent ... Peripheral artery disease is associated with poor clinical outcome in patients with abdominal aortic aneurysm after endovascular aneurysm repair ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05677100

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart ... The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37804307/

Safety and Performance of the Aortix Device in ... - PubMed This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05677100

Diuretics Alone vs. Aortix Endovascular Device for Acute ... The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care ...

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00367-5/fulltext

Safety and procedural success of daycase-based ... We aimed to examine the safety and efficacy of daycase-based lower extremity endovascular revascularisation procedures in patients with peripheral artery ...