Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01541865




Trial ID
NCT01541865
Ethics application status
Date submitted
21/02/2012
Date registered
27/02/2012
Date last updated
23/10/2015

Titles & IDs
Public title
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
Scientific title
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY
Secondary ID [1] 0 0
CR002-020
Universal Trial Number (UTN)
Trial acronym
REDUCE-HTN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

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

Other: Renal Denvervation - All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.


Treatment: Devices: Renal Denervation
percutaneous renal denervation using the Vessix RF balloon catheter

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

Outcomes
Primary outcome [1] 0 0
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment - Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .
Timepoint [1] 0 0
Baseline and 6 months
Primary outcome [2] 0 0
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure - Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.
Timepoint [2] 0 0
Baseline and 6 months
Secondary outcome [1] 0 0
Absence of Flow Limiting Stenosis in the Renal Artery - Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery
Timepoint [2] 0 0
Duration of the procedure (average of 65 minutes)
Secondary outcome [3] 0 0
Renal Artery Infarction or Embolus
Timepoint [3] 0 0
Duration of the procedure (average of 65 minutes)
Secondary outcome [4] 0 0
Cerebrovascular Accident (CVA) at Time of Procedure
Timepoint [4] 0 0
Duration of the procedure (average of 65 minutes)
Secondary outcome [5] 0 0
Myocardial Infarction at Time of Procedure
Timepoint [5] 0 0
Duration of the procedure (average of 65 minutes)
Secondary outcome [6] 0 0
Sudden Cardiac Death at Time of Procedure
Timepoint [6] 0 0
Duration of the procedure (average of 65 minutes)
Secondary outcome [7] 0 0
Angiographically-documented Renal Stenosis Requiring an Intervention
Timepoint [7] 0 0
2 Years
Secondary outcome [8] 0 0
Chronic Symptomatic Orthostatic Hypotension
Timepoint [8] 0 0
2 Years
Secondary outcome [9] 0 0
Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)
Timepoint [9] 0 0
2 Years
Secondary outcome [10] 0 0
Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%
Timepoint [10] 0 0
2 Years

Eligibility
Key inclusion criteria
1. Subjects who have provided written informed consent;

2. Subjects who are = 18 years and = 75 years of age;

3. Subjects who have Systolic Blood Pressure (SBP) = 160 mm Hg based on an average of
three (3) office-based blood pressure readings (seated) measured according to
protocol;

4. Subjects with = 3 anti-hypertensive drugs at maximally tolerated doses with stable
regimen for at least 2 weeks prior to enrollment

5. Subjects with a estimated glomerular filtration rate (eGFR) = 45 ml/min/1.73m^2;

6. Suitable renal artery anatomy

7. Subjects who are willing and able to comply with all study procedures.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with known/diagnosed secondary hypertension;

2. Subjects who are contraindicated for anticoagulation medications (heparin, aspirin,
Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic
medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for
an interventional procedure;

3. Subjects with known bleeding or hyper-coagulation disorders;

4. Subjects who have type 1 diabetes mellitus;

5. Subjects who have experienced a myocardial infarction, unstable angina pectoris,
uncompensated heart failure, or a cerebrovascular accident within six (6) months prior
to the screening visit, or have widespread atherosclerosis, with documented
intravascular thrombosis or unstable plaques;

6. Subjects who have planned percutaneous vascular or surgical intervention for any
reason within the next 6 months;

7. Subjects who have hemodynamically significant valvular heart disease for which
reduction of blood pressure would be considered hazardous;

8. Subjects who have an implantable cardioverter defibrillator, pacemaker, or clinically
significant abnormal electrocardiogram

9. Subjects who have any serious medical condition, which in the opinion of the
investigator, may adversely affect patient safety or the efficacy of the procedure in
the study (i.e., patients with clinically significant peripheral vascular disease,
abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or
significant anemia);

10. Subjects who are pregnant, nursing or planning to become pregnant;

11. Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;

12. Subjects who are currently enrolled in any investigational study wherein patient
participation has not been completed;

13. Subjects who, for any reason, may not be able to understand or comply with
instructions;

14. Subjects who are contraindicated for intravascular contrast material;

15. Subjects who are currently taking estrogen or any estrogen-like compound.

16. Subjects who have had a prior renal denervation procedure

17. Subjects with prior intervention to right or left renal artery;

18. Subjects with = 30% renal artery stenosis

19. Subjects with severe femoral, renal, iliac or aortic calcification that may cause a
potential complication at the time of the procedure;

20. Subjects in which the physician is unable to safely cannulate the renal artery;

21. Subjects in which the physician is unable to percutaneously access the femoral artery;

22. Subjects with one kidney.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital, Cardiology Clinical Research Centre - Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Monash Cardiovascular Research Centre (Monash Heart) - Clayton
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Belgium
State/province [3] 0 0
Aalst
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
France
State/province [6] 0 0
Toulouse
Country [7] 0 0
Germany
State/province [7] 0 0
Bad Berka
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Soden/Taunus
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Essen
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg
Country [13] 0 0
Germany
State/province [13] 0 0
Homburg/Saar
Country [14] 0 0
Germany
State/province [14] 0 0
Leipzig
Country [15] 0 0
Germany
State/province [15] 0 0
Münich
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Netherlands
State/province [17] 0 0
Rotterdam
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
Switzerland
State/province [19] 0 0
Geneva
Country [20] 0 0
Switzerland
State/province [20] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The Study objective is to assess the performance of the Vessix V2 Renal Denervation System
for the treatment of uncontrolled hypertension using an innovative percutaneous Radio
Frequency (RF) balloon catheter renal denervation device.
Trial website
https://clinicaltrials.gov/show/NCT01541865
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Horst Sievert, M.D.
Address 0 0
CardioVascular Center Frankfurt, Germany
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