Clinical Trial: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

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.

Detailed Summary:

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.


Sponsor: Boston Scientific Corporation

Current Primary Outcome:

  • Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment [ Time Frame: Baseline and 6 months ]
    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. .
  • Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure [ Time Frame: Baseline and 6 months ]
    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.


Original Primary Outcome: Acute safety of the procedure [ Time Frame: 24 hours ]

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.


Current Secondary Outcome:

  • Absence of Flow Limiting Stenosis in the Renal Artery [ Time Frame: 6 months ]
    Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound
  • Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery [ Time Frame: Duration of the procedure (average of 65 minutes) ]
  • Renal Artery Infarction or Embolus [ Time Frame: Duration of the procedure (average of 65 minutes) ]
  • Cerebrovascular Accident (CVA) at Time of Procedure [ Time Frame: Duration of the procedure (average of 65 minutes) ]
  • Myocardial Infarction at Time of Procedure [ Time Frame: Duration of the procedure (average of 65 minutes) ]
  • Sudden Cardiac Death at Time of Procedure [ Time Frame: Duration of the procedure (average of 65 minutes) ]
  • Angiographically-documented Renal Stenosis Requiring an Intervention [ Time Frame: 2 Years ]
  • Chronic Symptomatic Orthostatic Hypotension [ Time Frame: 2 Years ]
  • Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance) [ Time Frame: 2 Years ]
  • Reduction in Estimated Glomerular Filtration Rate (eGFR) >25% [ Time Frame: 2 Years ]


Original Secondary Outcome: A change in systolic and diastolic blood pressure [ Time Frame: 6 months ]

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.


Information By: Boston Scientific Corporation

Dates:
Date Received: February 21, 2012
Date Started: February 2012
Date Completion:
Last Updated: October 23, 2015
Last Verified: October 2015