Shockwave Assisted Large Bore Access

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

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.

Study Overview

• Status: Terminated
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: Plain old balloon angioplasty; Device: Shockwave

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morgan Overstreet, MS; Phone Number: 843-792-8896; Email: overstrm@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, </= 5mm slices
• Preoperative ABI/TP

• Unsuccessful delivery of large bore sheath without adjunctive intervention

  o Definition of unsuccessful = operator assessment of the following

• Visible distortion of iliac artery calcification under fluoroscopy without forward progress of device
• Adverse forward pressure application by operator
• Failure of device to track with external pressure applied to abdomen
• Patient intolerance of advancement (pain response) in awake patient

Exclusion Criteria:

• Contraindicated for antiplatelet therapy (aspirin or plavix)
• Planned iliofemoral surgical reconstruction in next 30 days
• Prior common or external iliac artery stent placement
• Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present
• Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required
• Inability to obtain preoperative CTA (contrast allergy, CKD, etc)
• Inability to traverse iliac segment with wire
• Emergent procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard POBA (plain old balloon angioplasty); The first 50 patients will be pre-treated with standard POBA	Device: Plain old balloon angioplasty; POBA
Experimental: Shockwave; The second 50 patients will be treated primarily with Shockwave	Device: Shockwave; Shockwave Medical, Inc. Peripheral Lithoplasty® System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful advancement of planned large bore access device	Technical success-defined as successful advancement of planned large bore access device without use of additional adjuncts (stenting, repeat shockwave treatment, high pressure balloon, alternative access pathway)	Day 1

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Shockwave Medical, Inc.
• Investigators: Principal Investigator: Mathew Wooster, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Vascular Surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 00103170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes