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Shockwave Assisted Large Bore Access

Primary Purpose

Vascular Diseases

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shockwave
Plain old balloon angioplasty
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Diseases focused on measuring Vascular Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard POBA (plain old balloon angioplasty)

Shockwave

Arm Description

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

The second 50 patients will be treated primarily with Shockwave

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 19, 2020
Last Updated
September 28, 2023
Sponsor
Medical University of South Carolina
Collaborators
Shockwave Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04600934
Brief Title
Shockwave Assisted Large Bore Access
Official Title
Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
September 28, 2023 (Actual)
Study Completion Date
September 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Shockwave Medical, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
Keywords
Vascular Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard POBA (plain old balloon angioplasty)
Arm Type
Active Comparator
Arm Description
The first 50 patients will be pre-treated with standard POBA
Arm Title
Shockwave
Arm Type
Experimental
Arm Description
The second 50 patients will be treated primarily with Shockwave
Intervention Type
Device
Intervention Name(s)
Shockwave
Intervention Description
Shockwave Medical, Inc. Peripheral Lithoplasty® System
Intervention Type
Device
Intervention Name(s)
Plain old balloon angioplasty
Intervention Description
POBA
Primary Outcome Measure Information:
Title
Successful advancement of planned large bore access device
Description
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)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew Wooster, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Shockwave Assisted Large Bore Access

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