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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01835535




Registration number
NCT01835535
Ethics application status
Date submitted
17/04/2013
Date registered
19/04/2013
Date last updated
26/03/2014

Titles & IDs
Public title
Continued Safety and Performance of the TIVUS System
Scientific title
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension
Secondary ID [1] 0 0
CLN02-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Resistant to Conventional Therapy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TIVUS

Experimental: Severe Resistant HTN - Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater


Treatment: Devices: TIVUS
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
Timepoint [1] 0 0
6 month
Secondary outcome [1] 0 0
Procedural complications
Timepoint [1] 0 0
30 day
Secondary outcome [2] 0 0
Major Adverse Events (MAE)
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Preservation of renal function
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Cardiovascular complications
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Blood pressure reduction
Timepoint [5] 0 0
1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2016
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cardiosonic
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01835535
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Jonas, MD
Address 0 0
Kaplan Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01835535