Clinical trial NCT05862558: Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Official title: Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iliac Disease
Aortic Valve Stenosis
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Shockwave Medical, Inc.
First posted: 2023-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects must meet the inclusion criteria and have none of the exclusion criteria to be eligible for participation in this study.

Brief summary: 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)

Detailed description: The goal of this post-market, prospective, observational single-arm cohort study is 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). This is a study of patients referred to BSW The Heart Hospital, Plano for evaluation of critical aortic stenosis. Those planned to undergo TAVR, have prohibitive iliofemoral disease, and otherwise considered for alternative access, will be considered for the study. The medical devices being used are in the post-market stage as it is being used in accordance with its approved labeling, treating iliofemoral disease.

Study data will be recorded prospectively on dedicated Data Collection Forms and stored locally in a secure format. De-identified data will be uploaded for statistical analysis. IRB approval for the study will be obtained.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Acute technical success per the DISRUPT PAD definition at the time of intervention
timeFrame: At time of IVL procedure
measure: Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment
timeFrame: At the time of TAVR procedure
Secondary outcomes:
measure: Applicable VARC-3 criteria at the time of peripheral intervention for bleeding, access site and access related complications.
timeFrame: At IVL procedure
measure: Major adverse events within 1 year
timeFrame: 1 year after IVL procedure
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott and White Heart Hospital
state: Texas
Study officials:
References:
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