Shockwave Assisted Large Bore Access

NCT04600934 | Withdrawn FDA Device

• 1 other identifier: 00103170
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vascular Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard POBA (plain old balloon angioplasty)

ACTIVE COMPARATOR

The first 50 patients will be pre-treated with standard POBA

Device: Plain old balloon angioplasty

Shockwave

EXPERIMENTAL

The second 50 patients will be treated primarily with Shockwave

Device: Shockwave

Interventions

Shockwave DEVICE

Shockwave Medical, Inc. Peripheral Lithoplasty® System

Shockwave

Plain old balloon angioplasty DEVICE

POBA

Standard POBA (plain old balloon angioplasty)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Mathew Wooster, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: October 3, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: September 3, 2024

Record last verified: 2023-09

Locations

US (1)