NCT04600934

Shockwave Assisted Large Bore Access

Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	Shockwave	Shockwave Medical, Inc. Peripheral Lithoplasty® System
DEVICE	Plain old balloon angioplasty	POBA

Timeline

• Start date: 2022-10-03
• Primary completion: 2023-09-28
• Completion: 2023-09-28
• First posted: 2020-10-23
• Last updated: 2024-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study