RECRUITING

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

Conditions

Common Femoral Artery Stenosis Calcification; Heart

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-07

Study Completion:2026-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06829914

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Bonnie Ostergren

CONTACT

469-814-4181

Bonnie.Ostergren@BSWHealth.org

Sarah Hale

CONTACT

469-814-4845

Sarah.Hale@BSWHealth.org

Principal Investigator

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 Locations (Sites)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-07

Study Completion Date2026-03-30

Study Record Updates

Study Start Date2024-03-07

Study Completion Date2026-03-30

Terms related to this study

Additional Relevant MeSH Terms

Common Femoral Artery Stenosis
Calcification; Heart