CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05145478
Status
Recruiting
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Conditions

  • Claudication
  • Critical Limb Ischemia
  • Femoral Arterial Calcification
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Shockwave Intravascular Lithotripsy (IVL) — DEVICE
    Eligible patients with atherosclerotic lesions in the femoral artery who either have claudication or critical limb ischemia will receive endovascular treatment in addition to be treated with Shockwave Intravascular Lithotripsy (IVL) technology.

Study Details

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

Key Dates

Start date
Dec 1, 2021
Status verified
Nov 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Shockwave Intravascular Lithotripsy (IVL)
    Patients with calcified common-femoral artery disease, who are eligible to receive IVL per the FDA indications.

Primary Outcome Measure

Change in Generic Health Status [ Time Frame: Baseline and 30 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HealthNew HavenConnecticut06510
Carlos Mena-Hurtado, MD
The Miriam HospitalProvidenceRhode Island02906
Peter A Soukas, MD
[email protected]
401-793-4105

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