NCT03914157

Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Researchers are evaluating a noninvasive treatment with ultrasound waves for Atherosclerotic Renal Artery Stenosis (ARAS).

Detailed description

Investigators will study 30 patients with ARAS randomized to SWT or sham (n=15 each) twice a week over 3 weeks. We will measure before and again 3 months after a 3-wk regimen renal cortical and medullary perfusion and function (multi-detector computed tomography \[MDCT\]), oxygenation, and fibrosis (magnetic resonance imaging \[MRI\]), urinary and plasma levels of renal injury markers, systemic endothelial function, and heart rate variability, an index of sympathetic activation.

Conditions

• Renal Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Low-energy extracorporeal ultrasound shockwave therapy (SWT)	SWT delivers 10% energy of the traditional SWT used for clinically indicated lithotripsy, evokes neovascularization, and improves regional blood flow and function in various ischemic tissues.

Timeline

• Start date: 2023-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2019-04-16
• Last updated: 2023-05-09

Regulatory

• FDA-regulated device study