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

Baylor Scott and White Health (BSWH)

Status: Enrolling

Conditions: Common Femoral Artery Stenosis; Calcification; Heart

Treatments: Device: Shockwave Catheter; Procedure: CFA Endarterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06829914

021-263

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Shockwave Catheter

Active Comparator group

Description:

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

Treatment:

Device: Shockwave Catheter

surgical endarterectomy

Active Comparator group

Description:

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

Treatment:

Procedure: CFA Endarterectomy