Hypertension
Conditions
Keywords
hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension
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.
Interventions
DEVICERenal Denervation
percutaneous renal denervation using the Vessix RF balloon catheter
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Reduction in Estimated Glomerular Filtration Rate (eGFR) >25% | 2 Years | — |
| Angiographically-documented Renal Stenosis Requiring an Intervention | 2 Years | — |
| Chronic Symptomatic Orthostatic Hypotension | 2 Years | — |
| Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance) | 2 Years | — |
| Sudden Cardiac Death at Time of Procedure | Duration of the procedure (average of 65 minutes) | — |
| 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 |
Countries
Australia, Austria, Belgium, France, Germany, Netherlands, New Zealand, Switzerland
Participant flow
Recruitment details
Enrollment of up to 150 subjects was planned; 146 subjects were enrolled at 23 centers in the Europe, Australia and New Zealand from February 22, 2012 to April 8, 2013.
Participants by arm
| Arm | Count |
|---|---|
| Renal Denervation All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System. | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Renal Denervation |
|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 10.4 |
| Antihypertensive Medications Subjects on 2 medications | 3 participants |
| Antihypertensive Medications Subjects on 3 medications | 26 participants |
| Antihypertensive Medications Subjects on 4 medications | 38 participants |
| Antihypertensive Medications Subjects on greater than or equal to 5 medications | 79 participants |
| Baseline Diastolic Blood Pressure | 100.2 mm Hg STANDARD_DEVIATION 14 |
| Baseline Systolic Blood Pressure | 182.4 mm Hg STANDARD_DEVIATION 18.4 |
| Congestive Heart Failure Congestive Heart Failure | 3 participants |
| Congestive Heart Failure No Congestive Heart Failure | 143 participants |
| Coronary Artery Disease Coronary Artery Disease | 55 participants |
| Coronary Artery Disease No Coronary Artery Disease | 91 participants |
| Dyslipidemia Dyslipidemia | 85 participants |
| Dyslipidemia No Dyslipidemia | 61 participants |
| Estimated glomerular filtration rate (eGFR) | 82.7 mL/min/1.73m^2 STANDARD_DEVIATION 22.5 |
| Heart Rate | 71.7 beats/min STANDARD_DEVIATION 14.8 |
| Number of Antihypertensive Medications per Patient | 4.8 Antihypertensive Medications per Patient STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Black, Asian, Other | 11 participants |
| Race/Ethnicity, Customized White | 135 participants |
| Region of Enrollment Australia | 31 participants |
| Region of Enrollment Austria | 13 participants |
| Region of Enrollment Belgium | 17 participants |
| Region of Enrollment France | 8 participants |
| Region of Enrollment Germany | 49 participants |
| Region of Enrollment Netherlands | 5 participants |
| Region of Enrollment New Zealand | 21 participants |
| Region of Enrollment Switzerland | 2 participants |
| Serum Creatinine | 82.0 micromol/L STANDARD_DEVIATION 20 |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 89 Participants |
| Type 2 Diabetes Non-Diabetic | 105 participants |
| Type 2 Diabetes Type 2 Diabetes | 41 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / 146 |
| serious Total, serious adverse events | 69 / 146 |
Outcome results
Primary
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.
Time frame: Baseline and 6 months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure | Systolic | -8.0 mm Hg | Standard Deviation 14.6 |
| Renal Denervation | Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure | Diastolic | -5.7 mm Hg | Standard Deviation 9.2 |
Primary
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. .
Time frame: Baseline and 6 months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment | Systolic | -24.5 mm Hg | Standard Deviation 22.1 |
| Renal Denervation | Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment | Diastolic | -10.3 mm Hg | Standard Deviation 12.7 |
Secondary
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
Time frame: 6 months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Absence of Flow Limiting Stenosis in the Renal Artery | 139 participants w/o flow limiting stenosis |
Secondary
Angiographically-documented Renal Stenosis Requiring an Intervention
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Angiographically-documented Renal Stenosis Requiring an Intervention | 1 participants |
Secondary
Cerebrovascular Accident (CVA) at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Cerebrovascular Accident (CVA) at Time of Procedure | 0 participants |
Secondary
Chronic Symptomatic Orthostatic Hypotension
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Chronic Symptomatic Orthostatic Hypotension | 0 participants |
Secondary
Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance) | 10 participants |
Secondary
Myocardial Infarction at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Myocardial Infarction at Time of Procedure | 0 participants |
Secondary
Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Reduction in Estimated Glomerular Filtration Rate (eGFR) >25% | 16 participants |
Secondary
Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery
Time frame: Duration of the procedure (average of 65 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery | 0 participants |
Secondary
Renal Artery Infarction or Embolus
Time frame: Duration of the procedure (average of 65 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Renal Artery Infarction or Embolus | 0 participants |
Secondary
Sudden Cardiac Death at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Sudden Cardiac Death at Time of Procedure | 0 participants |