Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01541865
First received: February 21, 2012
Last updated: April 4, 2014
Last verified: April 2014

February 21, 2012
April 4, 2014
February 2012
November 2013   (final data collection date for primary outcome measure)
A change in systolic and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Reduction of 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. Reduction of systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline.
Acute safety of the procedure [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Acute safety of the renal denervation procedure shall be determined based on no renal artery dissection or perforation during the procedure that requires stenting or surgery; no renal artery infarction or embolus; no cerebrovascular Accident and no myocardial infarction and no sudden cardiac death at the time of the procedure or the following 24 hours.
Complete list of historical versions of study NCT01541865 on ClinicalTrials.gov Archive Site
Absence of flow limiting stenosis in the renal artery [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound
A change in systolic and diastolic blood pressure [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Reduction of systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment (seated) following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. Reduction of systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline.
Not Provided
Not Provided
 
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

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 RF balloon catheter renal denervation device.

This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be employed to reduce systolic and diastolic blood pressure at 6 months as compared to pre-treatment baseline blood pressures.

Patient blood pressure will be measured by in the office according to recognized international techniques and standards.

Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Device: Renal Denervation
percutaneous renal denervation using the Vessix RF balloon catheter
Other Name: Vessix V2 Renal Denervation System
single arm
single arm cohort study
Intervention: Device: Renal Denervation
Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
May 2015
November 2013   (final data collection date for primary outcome measure)

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 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 eGFR ≥ 45 ml/min per 1.73m2;
  6. Suitable renal artery anatomy
  7. Subjects who are willing and able to comply with all study procedures.

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Austria,   New Zealand,   Germany,   France,   Belgium,   Australia,   Switzerland
 
NCT01541865
CR002-020
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Horst Sievert, M.D. CardioVascular Center Frankfurt, Germany
Boston Scientific Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP