Clinical trial NCT01835535: Continued Safety and Performance of the TIVUS System
Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hypertension, Resistant to Conventional Therapy
Lead sponsor: Cardiosonic
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
timeFrame: 6 month
Secondary outcomes:
measure: Procedural complications
timeFrame: 30 day
measure: Major Adverse Events (MAE)
timeFrame: 1 year
measure: Preservation of renal function
timeFrame: 1 year
measure: Cardiovascular complications
timeFrame: 1 year
measure: Blood pressure reduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
Study officials:
affiliation: Kaplan Medical Center
name: Michael Jonas, MD
role: PRINCIPAL_INVESTIGATOR
References: