Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Description

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)

Conditions

Iliac Disease, Aortic Valve Stenosis

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Study Overview

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Study Details

Study overview

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)

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Condition
Iliac Disease
Intervention / Treatment

-

Contacts and Locations

Plano

Baylor Scott and White Heart Hospital, Plano, Texas, United States, 75093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
  • 2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
  • 3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
  • 4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
  • 5. Subjects can provide written, informed consent.
  • 1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
  • 2. Subject who has contraindications to IVL
  • 3. Subject who has contraindications or is not eligible for TAVR

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor Research Institute,

Study Record Dates

2025-12