slow enrollment

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.

Inclusion Criteria:

• Age >18 years
• Indicated for planned procedure requiring large bore (>12 French sheath) access
• Mental capacity to provide informed consent
• Iliac access vessel demonstrates >50% circumferential calcium
• Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required
• Iliac access vessel demonstrates maximum outer wall diameter greater than or equal to IFU for device required
• Preoperative CT angiogram, \