Shockwave Assisted Large Bore Access

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04600934
• Other study ID #: 00103170
• Status: Terminated
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: September 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• Shockwave
Shockwave Medical, Inc. Peripheral Lithoplasty® System
• Plain old balloon angioplasty
POBA

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Shockwave Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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