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Clinical Trials/NCT01835535
NCT01835535UnknownPhase 2

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension

Cardiosonic1 site in 1 country80 target enrollmentStarted: August 1, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Enrollment
80
Locations
1
Primary Endpoint
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:

  • TIVUS™ Severe Resistant HTN Cohort
  • TIVUS™ Moderate Resistant HTN Cohort
  • TIVUS™ Failed RF Therapy Cohort

Study Design

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

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient is ≥ 18 and ≤ 80 years of age
  • •For Cohort A: Documented office systolic blood pressure > 160 mmHg (> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure > 140 mmHg (> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure > 150 mmHg (> 140 mmHg for diabetic patients)
  • •Documented 24 hour systolic ABPM > 135 mmHg
  • •Adherence to a stable drug regimen
  • •For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening
  • •Suitable renal artery anatomy
  • •Male or non-pregnant / non-lactating female
  • •Patient understands the nature of the procedure and provides written informed consent
  • •Patient is willing and able to comply with the specified study requirements and follow-up evaluations

Exclusion Criteria

  • •eGFR < 45mL/min/1.73m2
  • •Documented primary pulmonary hypertension
  • •Patient experienced >1 episode of orthostatic hypotension coupled with syncope
  • •Documented indicator of a secondary renal hypertension
  • •History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months
  • •Planned major surgery or cardiovascular intervention in the next 6 months
  • •Surgery or cardiovascular intervention in the previous 3 months
  • •Hemodynamically significant valvular heart disease
  • •Severe debilitating lung disease
  • •Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization
  • •Patient has a single functioning kidney
  • •Documented thrombocytopenia, clotting disorders or aortic aneurysms
  • •Moribund patient, or patient with comorbidities limiting life expectancy to less than one year
  • •Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication
  • •Concurrent enrollment in another trial
  • •Main renal arteries < 4 mm in lumen diameter or < 20 mm in length
  • •Aorto-renal angle that prevents a safe cannulation of the renal artery
  • •Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure
  • •Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
  • •Any renal artery stenosis > 50% by visual assessment
  • •Any renal artery aneurysm in either renal artery
  • •A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)

Arms & Interventions

Severe Resistant HTN

Experimental

Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater

Intervention: TIVUS (Device)

Outcomes

Primary Outcomes

Change in office Systolic Blood Pressure (SBP) from baseline to 6-month

Time Frame: 6 month

Secondary Outcomes

  • Blood pressure reduction(1 year)
  • Procedural complications(30 day)
  • Major Adverse Events (MAE)(1 year)
  • Cardiovascular complications(1 year)
  • Preservation of renal function(1 year)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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