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

Description

The investigators hypothesize that Shockwave with DCB is non-inferior to surgical endarterectomy for common femoral artery (CFA) stenosis with regard to primary efficacy and safety endpoints. The study will challenge the current guideline that recommends common femoral endarterectomy (CFE) as the primary treatment for symptomatic CFA stenosis.

Conditions

Common Femoral Artery Stenosis, Calcification; Heart

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Study Overview

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Study Details

Study overview

The investigators hypothesize that Shockwave with DCB is non-inferior to surgical endarterectomy for common femoral artery (CFA) stenosis with regard to primary efficacy and safety endpoints. The study will challenge the current guideline that recommends common femoral endarterectomy (CFE) as the primary treatment for symptomatic CFA stenosis.

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

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

Condition
Common Femoral Artery Stenosis
Intervention / Treatment

-

Contacts and Locations

Plano

Baylor Scott & White The Heart Hospital - Plano, Plano, Texas, United States, 75093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor Research Institute,

Sameh Sayfo, MD, PRINCIPAL_INVESTIGATOR, Baylor Scott & White The Heart Hospital - Plano

John Kedora, MD, PRINCIPAL_INVESTIGATOR, Baylor Scott & White The Heart Hospital - Plano

Study Record Dates

2026-03-30