Shockwave vs Surgical Endarterectomy for Common Femoral Artery Stenosis

(Shockify Trial)

Overseen By Sarah Hale

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: Anticoagulants

Disqualifiers: CFE history, Thrombosis, Aneurysm, others

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

Compensation: Varies

Number of Visits: 31

Duration: Procedure date

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for narrowing in the thigh's main artery, common in individuals with lifestyle-limiting leg pain or severe circulation issues. Researchers aim to determine if a Shockwave Catheter, which uses sound waves to break up blockages, is as effective and safe as traditional artery-clearing surgery (CFA Endarterectomy). Candidates for this trial have significant artery narrowing and have not found relief with other treatments. As an unphased trial, this study provides a unique opportunity for patients to explore innovative treatment options that could enhance their quality of life.

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 cannot tolerate dual antiplatelet therapy (DAPT), you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Shockwave Catheter, used to treat narrowed arteries, is safe for people. Studies have found that this treatment works well and is easy for patients to handle, even for those with hard, calcified blockages. For instance, one study showed that patients who received the Shockwave Catheter had good results without serious side effects. Another study confirmed its safety, demonstrating similar positive outcomes for many patients with complicated artery issues.

Surgical endarterectomy is a common procedure with a well-known safety record. It involves removing blockages from arteries and is generally easy for patients to tolerate. Both treatments have a strong safety record, making them good options for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for common femoral artery stenosis because they offer innovative approaches compared to traditional surgical options like endarterectomy. The Shockwave Catheter uses Shockwave™ Intravenous Lithotripsy (IVL) combined with a Drug Coated Balloon (DCB), which is a novel method that employs sound waves to break up calcium deposits and then deliver medication directly to the artery. This approach could potentially reduce the need for invasive surgery and shorten recovery time. On the other hand, surgical endarterectomy, while effective, involves patch angioplasty, which is more invasive. By comparing these methods, researchers hope to find a less invasive yet effective alternative for treating this condition.

What evidence suggests that this trial's treatments could be effective for common femoral artery stenosis?

Research has shown that Shockwave Catheter treatment, which uses sound waves to break up hard plaque in arteries, holds promise for treating narrowed arteries. Studies consistently demonstrate its effectiveness and safety, even in challenging cases with very hard arteries. For instance, one study found significant improvement in artery narrowing while maintaining procedural safety. Another study showed that after using the Shockwave Catheter, only about 15% narrowing remained on average. In this trial, participants will receive either the Shockwave Catheter treatment or surgical endarterectomy, which involves removing plaque from the artery. These results suggest that the Shockwave Catheter could be a good option for narrowing in the common femoral artery. ^{1 2 3 4 5}

Who Is on the Research Team?

Sameh Sayfo, MD

Principal Investigator

Baylor Scott & White The Heart Hospital - Plano

John Kedora, MD

Principal Investigator

Baylor Scott & White The Heart Hospital - Plano

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe artery blockage in the leg, specifically the common femoral artery. They should have tried other treatments without success and suffer from symptoms like pain while walking or critical limb issues. Candidates must not have had recent heart attacks, strokes, previous surgeries on the affected limb, be pregnant, or unable to take blood thinners.

Inclusion Criteria

I am eligible for surgery before joining the study.

Moderate to severe calcification reported on imaging

Confirmed CFA atherosclerotic stenosis 60-100%

Exclusion Criteria

I have a blood clot in the main artery of my leg.

I cannot walk by myself.

I had a heart procedure without surgery less than 2 weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Shockwave™ IVL + DCB procedure or standard surgical endarterectomy

Procedure date

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person and virtual) at 30 days, 3 months, 6 months, and 1 year post-op

Long-term outcomes assessment

Assessment of long-term efficacy and safety outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CFA Endarterectomy
• Shockwave Catheter

Trial Overview The study tests if using a Shockwave catheter with drug-coated balloons is as effective and safe as surgical removal of artery blockages (endarterectomy) for patients with calcified leg artery stenosis. It challenges current guidelines favoring surgery for such conditions.

How Is the Trial Designed?

Group I: surgical endarterectomy Active Control 1 Intervention

Surgery should be performed with patch angioplasty, with or without profunda femoris endarterectomy.

Group II: Shockwave Catheter Active Control 1 Intervention

Shockwave™ Intravenous Lithotripsy (IVL)+ DCB (Drug Coated Balloon)

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Published Research Related to This Trial

Common femoral endarterectomy (CFE) shows higher primary patency rates compared to endovascular therapy for treating atherosclerotic stenosis of the common femoral artery, but it also comes with greater morbidity and mortality risks.

Endovascular interventions have lower complication rates and high technical success, but they may require more repeat procedures to maintain effectiveness, indicating a need for further research to determine the best treatment approach for CFA stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Isolated Atherosclerotic Stenosis of the Common Femoral Artery: A Review of the Literature. Halpin, D., Erben, Y., Jayasuriya, S., et al.[2022]

Common femoral endarterectomy (CFE) demonstrated a high technical success rate of 100% and a hemodynamic success rate of 95%, with significant improvements in patient symptoms and ankle-brachial index (ABI) after the procedure.

With a follow-up of 27 months, CFE showed excellent long-term outcomes, including 1- and 5-year primary patencies of 93% and 91%, respectively, supporting its position as the standard treatment for occlusive disease of the common femoral artery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common femoral artery occlusive disease: contemporary results following surgical endarterectomy. Kang, JL., Patel, VI., Conrad, MF., et al.[2022]

In a study of 33 patients treated with self-expandable nitinol stents for common femoral artery lesions, the procedure achieved a 100% technical success rate with no complications, indicating it is a safe intervention.

Long-term follow-up showed high patency rates of 79.5% after 24 and 60 months, suggesting that CFA stent placement is an effective alternative to traditional surgery for managing atherosclerotic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Femoral Artery Stenting: Computed Tomography Angiography Based Long-Term Patency. Martin, R., Vanesa G, DC., Raleigh, JV., et al.[2022]

In a study of 147 patients with calcified common femoral artery (CFA) disease treated with orbital atherectomy, the procedure showed a lower rate of angiographic complications (17%) compared to those with superficial femoral artery (SFA) disease (24%), indicating a safer profile for CFA treatment.

The CFA group experienced a lower dissection rate (10% vs 15% in SFA), suggesting that orbital atherectomy is an effective method for plaque modification in CFA disease, although further randomized trials are needed to establish the best treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute procedural outcomes of orbital atherectomy for the treatment of common femoral artery disease: Sub-analysis of the CONFIRM Registries. Lee, MS., Heikali, D., Mustapha, J., et al.[2018]

In a study of 30 patients treated with endovascular therapy for common femoral artery disease, the procedure had a high technical success rate of 90% and no procedure-related mortality, indicating it is a safe option for patients.

The one-year primary patency rate for patients who underwent successful revascularization was 88%, with excellent outcomes for those treated for access-site-related complications and thromboembolic disease, suggesting an endovascular-first approach is effective for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and medium-term outcomes of endovascular therapy of obstructive disease of diverse etiology of the common femoral artery. Dattilo, PB., Tsai, TT., Kevin Rogers, R., et al.[2022]

The BAMBOO SPEAR technique, which involves directly puncturing calcified plaques in the common femoral artery with a metal needle, has shown promising results in treating occlusive lesions, as demonstrated in a case study of a 73-year-old male with severe ischemia.

This innovative approach allows for successful guidewire passage and subsequent balloon angioplasty, potentially improving outcomes for patients with challenging calcified arterial blockages where traditional methods may fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct bare metal needle puncture and balloon angioplasty in calcified plaques of the common femoral artery guided by angiography ("BAMBOO SPEAR"). Hayakawa, N., Kodera, S., Arakawa, M., et al.[2022]

Patients treated with an interwoven nitinol wire stent for common femoral artery atherosclerotic disease showed similar patency rates compared to those who underwent surgical endarterectomy, with rates of 95.5% for stents and 94.4% for endarterectomy after 12 months.

The stent group experienced greater clinical improvement, a shorter hospital stay (3 days vs 7 days), and a lower incidence of severe adverse events (0 cases vs 9 cases), indicating a potentially safer and more efficient treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of Interwoven Nitinol Wire Stent Placement versus Endarterectomy for the Treatment of Atherosclerotic Disease of the Common Femoral Artery. Allan, RB., Puckridge, PJ., Travers, EJ., et al.[2023]

The novel 'fracking technique' (FT) for modifying calcified plaques in the common femoral artery (CFA) has shown promising results, achieving significant increases in lumen area (MLA) in two case studies without complications.

In both cases, the FT resulted in larger MLA measurements (27.1 mm² and 28.9 mm²) compared to conventional balloon angioplasty, and no restenosis was detected during a 2-year follow-up, indicating its potential efficacy for treating calcified lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "Fracking" technique: a novel approach to crack deep calcified plaque in the common femoral artery with hydraulic pressure. Haraguchi, T., Fujita, T., Kashima, Y., et al.[2022]

Citations

1. shockwavemedical.com shockwavemedical.com/news/shockwave-confirms-consistent-outcomes-for-ivl-in-the-largest-prospective-real-world-study/

Shockwave Confirms Consistent Outcomes For IVL In The ... “The significant amount of data on IVL continue to show both consistent efficacy and safety across the most challenging lesions, various ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07205068

Improved Outcomes With Pre-Procedure Shockwave IVL of ... This is a prospective randomized/control trial pilot study to compare clinical outcomes of common femoral artery access in patients undergoing ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38877777/

Intravascular Lithotripsy for Treatment of Severely Calcified ... Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772930325013079

Shockwave Versus Surgical Endarterectomy for Calcified ... We hypothesize that IVL combined with DCB will demonstrate noninferior safety and efficacy within 6 months and 1 year, respectively, compared to CFE. Materials ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(25)00960-7/fulltext

Mid-term outcomes of Shockwave intravascular lithotripsy ... Mean residual stenosis was 14.95% ± 14% at final angiogram. Extravascular ultrasound with improved imaging (bi-triphasic in place of monophasic/blunted ...