Shockwave Assisted Large Bore Access

NCT ID: NCT04600934

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2023-09-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard POBA (plain old balloon angioplasty)

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

Group Type: ACTIVE_COMPARATOR

Plain old balloon angioplasty

Intervention Type: DEVICE

POBA

Shockwave

The second 50 patients will be treated primarily with Shockwave

Group Type: EXPERIMENTAL

Shockwave

Intervention Type: DEVICE

Shockwave Medical, Inc. Peripheral Lithoplasty® System

Interventions

Shockwave

Shockwave Medical, Inc. Peripheral Lithoplasty® System

Intervention Type: DEVICE

Plain old balloon angioplasty

POBA

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Mathew Wooster

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mathew Wooster, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

00103170

Identifier Type: -

Identifier Source: org_study_id