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

NCT06829914 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-08

No results posted yet for this study

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.

Conditions

  • Common Femoral Artery Stenosis
  • Calcification; Heart

Interventions

DEVICE

Shockwave Catheter

Shockwave™ IVL + DCB procedure

PROCEDURE

CFA Endarterectomy

Standard CFA endarterectomy

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2026-03-07
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829914 on ClinicalTrials.gov