Comparing Shockwave treatment to surgery for severe artery blockage

Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes

This study is testing whether a new Shockwave treatment combined with a special balloon can help people with severe artery blockage feel better compared to traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baylor Research Institute (Academic / other)
• Locations: 1 site (Plano, Texas)
• Trial ID: NCT06829914 on ClinicalTrials.gov

What this trial studies

This pilot, prospective, randomized clinical trial investigates the efficacy and safety of Shockwave™ Intravascular Lithotripsy (IVL) combined with a drug-coated balloon (DCB) compared to traditional surgical endarterectomy for patients with severe symptomatic calcified common femoral artery stenosis. Participants will be randomized into two groups: one receiving the innovative Shockwave™ IVL + DCB treatment and the other undergoing standard surgical endarterectomy. The study aims to evaluate primary efficacy and safety outcomes at 1 year and 6 months post-procedure, respectively, challenging current treatment guidelines for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with severe calcified common femoral artery stenosis and lifestyle-limiting symptoms who are candidates for surgery.

Not a fit: Patients with a history of prior surgery on the affected limb or those with certain vascular complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive alternative to surgery for patients with severe common femoral artery stenosis.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using endovascular techniques for vascular conditions, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

A patient will be eligible for inclusion in this study if he or she meets all of the following criteria (confirmed by core lab):

1. CFA atherosclerotic stenosis 60-100%
2. Moderate to severe calcification reported on imaging
3. Lifestyle-limiting intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI) as described by Rutherford chronic limb ischemia (CLI) category 2-5
4. Failing conservative therapy
5. Operative candidate for CFE prior to enrollment
6. ≥18 years of age

Exclusion Criteria:

A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:

1. History of CFE or bypass in affected limb
2. Thrombosis of affected CFA
3. Aneurysm in the common femoral artery of target limb
4. Known target lesion restenosis (re-narrowing of the artery to ≥50% following the alleviation of a previous narrowing within 3 months)
5. Any preceding percutaneous cardiovascular intervention within 2 weeks
6. Inability to tolerate DAPT
7. Known coagulopathy or bleeding diathesis, thrombocytopenia with platelet count \<100,000/µL
8. Uncontrolled diabetes (HbA1c ≥10.0%)
9. Non-ambulatory
10. Extensive tissue loss requiring amputation or salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations
11. MI within 6 weeks (defined as presumed ischemic symptoms (chest pain, ST-segment deviation and troponin higher than 2 times the upper limit of normal))
12. Stroke within 3 months (defined as sudden transient or irreversible focal neurological deficit resulting from a cerebrovascular cause)
13. Pregnant

Where this trial is running

Plano, Texas

• Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Sameh Sayfo, MD — Baylor Scott & White The Heart Hospital - Plano
• Study coordinator: Bonnie Ostergren

Conditions Common Femoral Artery Stenosis; Calcification; Heart