Clinical trial NCT06829914: Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Official title: Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Common Femoral Artery Stenosis
Calcification; Heart
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized pilot study
Primary purpose: OTHER

Brief summary: 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.

Detailed description: This is a pilot, prospective, randomized clinical trial. This trial compares patients with severe symptomatic moderate to severe calcified CFA stenosis undergoing traditional gold standard CFA endarterectomy to innovative technique of endovascular treatment using Shockwave™ Intra vascular Lithotripsy (IVL) using M5+ balloon with Drug coated balloon to achieve removal and debulking of plaque and achieve luminal gain. Patients who meet inclusion criteria will be informed and consented by a clinical coordinator if they wish to participate in the trial. If participants are candidates for surgery, they will then be randomized into one of two cohorts, receiving either Shockwave™ IVL + DCB (drug-coated balloon) procedure or a standard surgical endarterectomy. The study compares the 1-year efficacy and 6-month safety outcomes post-procedure for patients with severe, symptomatic CFA stenosis receiving Shockwave™ IVL with DCB versus surgical endarterectomy.

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

Primary outcomes:
measure: Clinically driven target lesion revascularization (cdTLR (symptom-driven repeat revascularization of the index lesion))
timeFrame: Procedure date through 1-year post-op
measure: Restenosis to ≥ 50% of the target lesion on angiography or follow-up ultrasound
timeFrame: Procedure date through 1-year post-op
measure: Freedom from perioperative death
timeFrame: Procedure date through 30 days post-op
measure: Freedom from major adverse cardiovascular events (MACE (stroke, myocardial infarction (MI), cardiovascular death))
timeFrame: Procedure date through 30 days post-op
measure: Freedom from major adverse events
timeFrame: Procedure date through 6 months post-op
Secondary outcomes:
measure: Mortality
timeFrame: Procedure date through 1-year post-op
measure: Rutherford Chronic Limb Ischemia (CLI) Category
timeFrame: 30 days post-op, 3 months post-op, 6 months post-op, 1 year post-op
measure: Treatment satisfaction and quality of life (PAQ)
timeFrame: Pre-op, 30 days post-op, 6 months post-op, 1 year post-op
measure: Intraoperative blood transfusion > 4 minutes
timeFrame: Intra-op
measure: Procedural duration (minutes)
timeFrame: Intra-op
measure: Length of stay (days)
timeFrame: Procedure date through 1 year post-op
measure: Postoperative anemia requiring blood transfusion
timeFrame: Procedure date through 30 days post-op
measure: Readmissions
timeFrame: 30 days post-op, 30 days post-discharge
measure: Return to the operating room / angiography suite
timeFrame: 30 days post-op
measure: Access/surgical site complications
timeFrame: 30 days post-op, 6 months post-op
measure: Pneumonia (number of cases)
timeFrame: Procedure date through 30 days post-op
measure: Prolonged intubation
timeFrame: Procedure date through 30 days post-op
measure: Urinary tract infection
timeFrame: Procedure date through 30 days post-op
measure: Sepsis
timeFrame: Procedure date through 30 days post-op
measure: Septic shock
timeFrame: Procedure date through 30 days post-op
measure: Graft failure
timeFrame: Procedure date through 30 days post-op
measure: Cardiac arrest
timeFrame: Procedure date through 30 days post-op
measure: Myocardial infarction
timeFrame: Procedure date through 30 days post-op
measure: Acute kidney injury
timeFrame: Procedure date through 30 days post-op
measure: Dialysis
timeFrame: Procedure date through 30 days post-op
measure: Deep vein thrombosis
timeFrame: Procedure date through 30 days post-op
measure: Pulmonary embolism
timeFrame: Procedure date through 30 days post-op
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
Study officials:
affiliation: Baylor Scott & White The Heart Hospital - Plano
name: Sameh Sayfo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Scott & White The Heart Hospital - Plano
name: John Kedora, MD
role: PRINCIPAL_INVESTIGATOR
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