Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Part of paid clinical trials in Plano, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT05862558
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Valve Stenosis
  • Iliac Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Shockwave Balloon — DEVICE
    Intravascular lithotripsy (IVL) performed with the Shockwave balloon (Shockwave Medical Inc) enables treatment of calcified stenosis of the peripheral arteries by using sonic pressure waves to selectively disrupt superficial and deep calcium without impacting healthy tissue

Study Details

To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)

Key Dates

Start date
Mar 30, 2023
Status verified
Oct 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
50 participants (estimated)

Primary Outcome Measure

Acute technical success per the DISRUPT PAD definition at the time of intervention [ Time Frame: At time of IVL procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Scott and White Heart HospitalPlanoTexas75093
Denise Espinoza
[email protected]
4698144783
Sarah Hale
[email protected]
4698144845
Karim Al-Azizi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Plano, TX

By research site
Baylor Scott and White Heart Hospital· Plano, TX

Related Studies