ILIT: Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
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Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
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Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
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Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
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Subjects can provide written, informed consent.
Exclusion Criteria:
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Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
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Subject who has contraindications to IVL
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Subject who has contraindications or is not eligible for TAVR
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor Scott and White Heart Hospital | Plano | Texas | United States | 75093 |
Sponsors and Collaborators
- Baylor Research Institute
- Shockwave Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 022-277