Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Recruiting

• Conditions: Iliac Disease; Aortic Valve Stenosis

• Registration Number: NCT05862558
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-30
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-17
• Last Update Posted: 2023-05-17
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment	At the time of TAVR procedure	To know the efficacy of the treatment
Acute technical success per the DISRUPT PAD definition at the time of intervention	At time of IVL procedure	Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion

Secondary Outcome Measures

Name	Time	Method
Applicable VARC-3 criteria at the time of peripheral intervention for bleeding, access site and access related complications.	At IVL procedure	To understand the efficacy of the treatment
Major adverse events within 1 year	1 year after IVL procedure	need for emergency surgical revascularization of target limb, unplanned target limb major amputation (above the ankle), symptomatic thrombus or distal emboli that requires surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization, perforations that require an intervention, including bail-out stenting.

Trial Locations

Locations (1)

Baylor Scott and White Heart Hospital; 🇺🇸 Plano, Texas, United States