Shockwave Assisted Large Bore Access

Status Terminated

Clinical Trial Summary

Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging. The intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Vascular Diseases

Clinical Trial Details

NCT number	NCT04600934
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Terminated
Phase	N/A
Start date	October 3, 2022
Completion date	September 28, 2023

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