Intravascular Lithotripsy for Peripheral Arterial Disease

Not currently recruiting at 48 trial locations

Overseen By Jennifer Sullivan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shockwave Medical, Inc.

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Stroke, Renal disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 30

Duration: At procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called intravascular lithotripsy, which uses sound waves to break up calcium deposits in clogged arteries below the knee. The goal is to assess the safety and effectiveness of this approach for people with peripheral arterial disease, particularly those with severe artery narrowing that impairs walking or causes pain. It suits individuals with significant artery blockages below the knee and noticeable calcium buildup, which makes the arteries difficult to open. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance treatment options for peripheral arterial disease.

Do I need to stop my current medications for the trial?

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 specific medications with the trial team.

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

Research has shown that intravascular lithotripsy (IVL) is generally safe for treating hardened arteries in the legs. In one study of patients with peripheral artery disease (PAD), no deaths occurred 30 days after treatment, and only 0.8% of patients experienced serious limb problems, indicating very few had severe issues.

Another study found that IVL is safe for certain types of blockages in leg arteries. However, limited information exists on its long-term safety, so the complete picture remains unclear.

Overall, these studies suggest that IVL is well-tolerated in the short term, with few major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intravascular lithotripsy is unique because it uses sound waves to break up calcium deposits in peripheral arteries, which is different from traditional treatments like angioplasty and stenting. Unlike these standard treatments that physically open up blockages, lithotripsy specifically targets and disrupts the calcified plaques, potentially reducing the risk of artery damage. Researchers are excited about this approach because it offers a less invasive option with the potential for fewer complications and better long-term outcomes for patients with peripheral arterial disease.

What evidence suggests that intravascular lithotripsy is effective for peripheral arterial disease?

Research has shown that intravascular lithotripsy (IVL) effectively treats hardening in the arteries of the legs, known as peripheral artery disease (PAD). One study found that IVL reduced artery narrowing by 59.3%, marking a significant improvement. Another study reported no deaths, and only 0.8% of patients experienced major leg problems within 30 days. Patients also noted a noticeable improvement in their quality of life. These findings suggest that IVL is both safe and effective for managing tough artery blockages in the legs. Participants in this trial will receive IVL to further evaluate its effectiveness and safety. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with Peripheral Arterial Disease affecting the legs, specifically below-the-knee arteries. Participants must have a life expectancy over a year and be able to follow study procedures. They should have moderate to severe artery calcification or non-dilatable lesions, and not be allergic to certain materials like urethane or silicone.

Inclusion Criteria

Subject is able and willing to comply with all assessments in the study

I have up to 2 lesions below the knee in my legs.

The size of the blood vessels near the affected area should be between 2.0 mm and 4.0 mm as determined by the doctor.

Exclusion Criteria

A procedure done to open a blocked artery didn't work and caused serious complications that can be seen on X-ray images.

My procedure to cross a blockage in my blood vessel with a guidewire was unsuccessful.

I have untreated blockages in my leg arteries without serious complications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Shockwave Medical Peripheral IVL System for treatment of calcified, stenotic BTK arteries

At procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 30 days, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Intravascular Lithotripsy

Trial Overview The trial is testing the Shockwave Medical Peripheral IVL System's safety and effectiveness in treating calcified, narrowed arteries below the knee. It's an observational study where all participants receive Intravascular Lithotripsy (IVL) without being compared to another group.

How Is the Trial Designed?

Group I: Single-arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Shockwave Medical, Inc.

Lead Sponsor

Trials

38

Recruited

10,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39422234/

30-Day Outcomes From the Disrupt PAD III Observational ... Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified peripheral artery disease (PAD) in large trials and small real-world ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39536842/

Thirty-day outcomes from the Disrupt PAD BTK II study of ... At 30 days, there were no deaths, major adverse limb event rate was 0.8%, and mean improvement in Vascular Quality of Life scores was 4.0 ± 5.0 (P < .0001). Of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1078588421008194

Efficacy and Safety of Intravascular Lithotripsy in Lower ... The meta-analysis demonstrated that IVL achieved a 59.3% reduction in diameter stenosis percentage in lower limb extremity arterial stenoses. Vascular ...

4. shockwavemedical.com shockwavemedical.com/news/shockwave-medical-further-validates-utility-of-intravascular-lithotripsy-in-lower-limb-lesions-in-late-breaking-presentation-at-viva-2024/

Shockwave Medical Further Validates Utility Of ... DISRUPT BTK II, a global post-market study, finds favorable 30-day outcomes for peripheral IVL in the most challenging calcified lesions.

5. jvascsurg.org jvascsurg.org/article/S0741-5214(24)02063-9/fulltext

Thirty-day outcomes from the Disrupt PAD BTK II study ... At 30 days, there were no deaths, major adverse limb event rate was 0.8%, and mean improvement in Vascular Quality of Life scores was 4.0 ± 5.0 (P < .0001). •.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0741521424020639

Thirty-day outcomes from the Disrupt PAD BTK II study of ... At 30 days, there were no deaths, major adverse limb event rate was 0.8%, and mean improvement in Vascular Quality of Life scores was 4.0 ± 5.0 (P < .0001). •.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37853746/

Twelve-Month Outcomes of Intravascular Lithotripsy for ... Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of ...

8. scai.org scai.org/media-center/news-and-articles/disrupt-pad-iii-trial-demonstrates-safety-and-effectiveness

Disrupt PAD III Trial Demonstrates Safety and Effectiveness ... The Disrupt PAD III study provides the largest randomized controlled evidence to guide endovascular treatment of severely calcified superficial femoral artery- ...