Shockwave Assisted Large Bore Access

Overview

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.

Full Title of Study: “Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2022

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Standard POBA (plain old balloon angioplasty)
    • The first 50 patients will be pre-treated with standard POBA
  • Experimental: Shockwave
    • The second 50 patients will be treated primarily with Shockwave

Clinical Trial Outcome Measures

Primary Measures

  • Successful advancement of planned large bore access device
    • Time Frame: Day 1
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Collaborator
    • Shockwave Medical, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mathew Wooster, Assistant Professor – Medical University of South Carolina
  • Overall Official(s)
    • Mathew Wooster, MD, Principal Investigator, Medical University of South Carolina
  • Overall Contact(s)
    • Morgan Overstreet, MS, 843-792-8896, overstrm@musc.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.