Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
- Conditions
- Hypertension
- Interventions
- Device: Renal Denervation
- Registration Number
- NCT01541865
- Lead Sponsor
- Boston Scientific Corporation
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- Subjects who have provided written informed consent;
- Subjects who are ≥ 18 years and ≤ 75 years of age;
- 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;
- Subjects with ≥ 3 anti-hypertensive drugs at maximally tolerated doses with stable regimen for at least 2 weeks prior to enrollment
- Subjects with a estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m^2;
- Suitable renal artery anatomy
- Subjects who are willing and able to comply with all study procedures.
- Subjects with known/diagnosed secondary hypertension;
- 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;
- Subjects with known bleeding or hyper-coagulation disorders;
- Subjects who have type 1 diabetes mellitus;
- 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;
- Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months;
- Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;
- Subjects who have an implantable cardioverter defibrillator, pacemaker, or clinically significant abnormal electrocardiogram
- 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);
- Subjects who are pregnant, nursing or planning to become pregnant;
- Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;
- Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;
- Subjects who, for any reason, may not be able to understand or comply with instructions;
- Subjects who are contraindicated for intravascular contrast material;
- Subjects who are currently taking estrogen or any estrogen-like compound.
- Subjects who have had a prior renal denervation procedure
- Subjects with prior intervention to right or left renal artery;
- Subjects with ≥ 30% renal artery stenosis
- Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure;
- Subjects in which the physician is unable to safely cannulate the renal artery;
- Subjects in which the physician is unable to percutaneously access the femoral artery;
- Subjects with one kidney.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renal Denvervation Renal Denervation All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
- Primary Outcome Measures
Name Time Method Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment 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 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.
- Secondary Outcome Measures
Name Time Method Absence of Flow Limiting Stenosis in the Renal Artery 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 Duration of the procedure (average of 65 minutes) Renal Artery Infarction or Embolus Duration of the procedure (average of 65 minutes) Cerebrovascular Accident (CVA) at Time of Procedure Duration of the procedure (average of 65 minutes) Myocardial Infarction at Time of Procedure Duration of the procedure (average of 65 minutes) Sudden Cardiac Death at Time of Procedure Duration of the procedure (average of 65 minutes) Chronic Symptomatic Orthostatic Hypotension 2 Years Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance) 2 Years Reduction in Estimated Glomerular Filtration Rate (eGFR) >25% 2 Years Angiographically-documented Renal Stenosis Requiring an Intervention 2 Years
Trial Locations
- Locations (26)
AKH Linz
🇦🇹Linz, Austria
Salzburger Landeskliniken Universitats Krankenhaus
🇦🇹Salzburg, Austria
Erasmus Medical Center-Thorax Center
🇳🇱Rotterdam, Netherlands
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Clinic Pasteur
🇫🇷Toulouse, France
German Heart Center Munich
🇩🇪Münich, Germany
Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology
🇩🇪Homburg/Saar, Germany
University Leipzig
🇩🇪Leipzig, Germany
St. Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
The Prince Charles Hospital, Cardiology Clinical Research Centre
🇦🇺Brisbane, Queensland, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Monash Cardiovascular Research Centre (Monash Heart)
🇦🇺Clayton, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
OLV Ziekenhuis
🇧🇪Aalst, Belgium
Cliniques Universiaires Saint-Luc
🇧🇪Brussels, Belgium
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
Vascular Center Berlin, Ev. Königin Elisabeth Hospital
🇩🇪Berlin, Germany
Kardiologische Praxis Main-Taunus
🇩🇪Bad Soden/Taunus, Germany
Hamburg University Cardiovascular Center
🇩🇪Hamburg, Germany
CardioVascular Center, Sankt Katharinen Krakenhaus
🇩🇪Frankfurt, Germany
Mercy Angiography Unit Ltd
🇳🇿Auckland, New Zealand
Auckland City Hospital
🇳🇿Grafton, Auckland, New Zealand
Switzerland University Hospital Clinic for Cardiology
🇨🇭Zürich, Switzerland
University Hospital of Geneva, Cardiology Center
🇨🇭Geneva, Switzerland
St. Vincenz Krankenhaus Abt. Kardiologie
🇩🇪Essen, Germany