RECRUITING

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Quick Facts

Study Start:2023-03-30

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05862558

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.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Baylor Scott and White Heart Hospital

Plano, Texas, 75093

United States

Collaborators and Investigators

Sponsor: Baylor Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-30

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-03-30

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Iliac Disease
Aortic Valve Stenosis