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Clinical Trials/NCT01865591
NCT01865591UnknownEarly Phase 1

A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension

Sound Interventions, Inc.2 sites in 2 countries30 target enrollmentStarted: April 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Early Phase 1
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Major adverse events

Study Overview

Brief Summary

The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
  • Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
  • Renal artery diameter ≥5mm by digital angiography
  • Accessibility of renal vasculature

Exclusion Criteria

  • Estimated GFR < 45
  • Type 1 Diabetes
  • Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)

Arms & Interventions

Renal denervation

Experimental

Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.

Intervention: Ultrasound-based Renal Denervation (Device)

Outcomes

Primary Outcomes

Major adverse events

Time Frame: 30 days

All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure

Secondary Outcomes

  • Adverse events and device complications(12 months)
  • Change from baseline in creatinine(6 months)
  • Change from baseline in office blood pressure measurement(30 days, 3 months, 6 months, 9 months, 12 months)
  • Change from baseline in ambulatory 24-hour blood pressure measurement(6 months, 12 months)
  • Change from baseline in renal artery dimensions(30 days)

Investigators

Sponsor
Sound Interventions, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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