Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02392351
Collaborator
(none)
51
12
2
52
4.3
0.1
Study Details
Study Description
Brief Summary
The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).
Study Design
Study Type:
Interventional
Actual Enrollment
:
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE
Study Start Date
:
Apr 1, 2015
Actual Primary Completion Date
:
Sep 7, 2017
Actual Study Completion Date
:
Aug 2, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Renal Denervation Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). |
Device: Renal Denervation (Vessix)
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
Other Names:
|
| Sham Comparator: Masked Procedure Percutaneous renal angiography |
Device: Renal Angiography
Percutaneous renal angiography
Other Names:
|
Outcome Measures
Primary Outcome Measures
- OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks [Through 8 weeks]
Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)
Secondary Outcome Measures
- Number of Hospitalizations Due to Severe Hypotension/Syncope [Through 6 months]
Number of hospitalizations due to severe hypotension/syncope through 6 months.
- Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it [4 weeks]
Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.
- Renal Artery Dissection or Perforation Requiring Intervention [4 weeks]
Number of renal artery dissection or perforation requiring intervention through 4 weeks.
- Vascular Complications [4 weeks]
Number of vascular complications through 4 weeks.
- Significant New Renal Artery Stenosis [6 months]
Number of significant new renal artery stenosis events through 6 months.
- Number of Subjects Utilizing Anti-hypertensive Medications [3 months]
Number of subjects utilizing anti-hypertensive medications at 3 months.
- Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months [6 Months]
Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline
- Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months [6 Months]
Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.
- Number of Subjects Utilizing Anti-hypertensive Medications [6 months]
Number of subjects utilizing anti-hypertensive medications at 6 months
- Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure [12 Months]
Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months
- Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure [12 Months]
Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months
- All-Cause Death [24 Months]
Number of all causes of death through 24 months
- Number of Participants With Renal Failure [24 Months]
Number of renal failure events through 24 months
- Number of Participants With Hypertensive Crisis [24 Months]
Number of hypertensive crisis events through 24 months
- Mean Reduction in Average Office-based Systolic Blood Pressure [24 Months]
Mean Reduction in Average office-based systolic blood pressure through 24 months
- Mean Reduction in Average Office-based Diastolic Blood Pressure [24 Months]
Mean Reduction in Office-based diastolic blood pressure through 24 months
- Percent of Subjects at Target Blood Pressure [24 Months]
Percent of subjects at target blood pressure through 24 months
- Congestive Heart Failure [24 Months]
Number of subjects with congestive heart failure through 24 months
- Myocardial Infarction [24 Months]
Number of subjects who experience myocardial infarction through 24 months
- Stroke [24 Months]
Number of subjects experiencing stroke through 24 months
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age ≥18 and ≤75 years
-
OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements
-
Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg
-
For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
-
Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent
Exclusion Criteria:
-
Stenosis >30% or renal artery aneurysm in either renal artery
-
Fibromuscular dysplasia (FMD)
-
Known causes of secondary HTN
-
Type 1 diabetes mellitus
-
eGFR <40 mL/min/1.73m2
-
Known ejection fraction of <30% or heart failure that required hospitalization in the previous 6 months
-
Severe valvular heart disease
-
≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiology, PC | Birmingham | Alabama | United States | 35211 |
| 2 | Cedars - Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 3 | Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
| 4 | Cardiovascular Institute of the South | Houma | Louisiana | United States | 70360 |
| 5 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 6 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 7 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 8 | Albert Einstein Medical Center | Philadelphia | Pennsylvania | United States | 19141 |
| 9 | Wellmont CVA Heart Institute | Kingsport | Tennessee | United States | 37660 |
| 10 | Dallas Medical Center | Dallas | Texas | United States | 75006 |
| 11 | Cardiovascular Research Institute of Dallas | Dallas | Texas | United States | 75231 |
| 12 | Aspirus Heart and Vascular Institute | Wausau | Wisconsin | United States | 54401 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Martin B Leon, MD, Columbia University
- Principal Investigator: Michael Weber, MD, SUNY Downstate College of Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02392351
Other Study ID Numbers:
- S2333
First Posted:
Mar 19, 2015
Last Update Posted:
Feb 11, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Boston Scientific Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Period Title: Overall Study | ||
| STARTED | 34 | 17 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 34 | 17 |
Baseline Characteristics
| Arm/Group Title | Renal Denervation | Masked Procedure | Total |
|---|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography | Total of all reporting groups |
| Overall Participants | 34 | 17 | 51 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
58.5
(10.1)
|
58.2
(9.8)
|
58.4
(9.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
47.1%
|
4
23.5%
|
20
39.2%
|
| Male |
18
52.9%
|
13
76.5%
|
31
60.8%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian |
2
5.9%
|
0
0%
|
2
3.9%
|
| Caucasian |
27
79.4%
|
14
82.4%
|
41
80.4%
|
| Hispanic or Latino |
1
2.9%
|
1
5.9%
|
2
3.9%
|
| Black, of African Heritage |
6
17.6%
|
3
17.6%
|
9
17.6%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
34
100%
|
17
100%
|
51
100%
|
| Left Renal Artery (Count of Participants) | |||
| Count of Participants [Participants] |
34
100%
|
17
100%
|
51
100%
|
| Left Renal Accessory Artery (Count of Participants) | |||
| Count of Participants [Participants] |
5
14.7%
|
4
23.5%
|
9
17.6%
|
| Right Renal Artery (Count of Participants) | |||
| Count of Participants [Participants] |
34
100%
|
17
100%
|
51
100%
|
| Right Renal Accessory Artery (Count of Participants) | |||
| Count of Participants [Participants] |
5
14.7%
|
6
35.3%
|
11
21.6%
|
| Max Renal Artery Diameter (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
6.3
(1.3)
|
6.1
(1.2)
|
6.2
(1.3)
|
| Reference Renal Artery Diameter (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
5.4
(1.2)
|
5.5
(1.1)
|
5.5
(1.1)
|
| Renal Artery Length (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
42.0
(17.8)
|
46.3
(18.3)
|
43.6
(18.0)
|
Outcome Measures
| Title | OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks |
|---|---|
| Description | Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control) |
| Time Frame | Through 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 32 | 15 |
| Mean (Standard Deviation) [mmHg] |
-5.3
(10.1)
|
-8.5
(9.4)
|
| Title | Number of Hospitalizations Due to Severe Hypotension/Syncope |
|---|---|
| Description | Number of hospitalizations due to severe hypotension/syncope through 6 months. |
| Time Frame | Through 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it |
|---|---|
| Description | Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks. |
| Time Frame | 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Renal Artery Dissection or Perforation Requiring Intervention |
|---|---|
| Description | Number of renal artery dissection or perforation requiring intervention through 4 weeks. |
| Time Frame | 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Vascular Complications |
|---|---|
| Description | Number of vascular complications through 4 weeks. |
| Time Frame | 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Significant New Renal Artery Stenosis |
|---|---|
| Description | Number of significant new renal artery stenosis events through 6 months. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number of Subjects Utilizing Anti-hypertensive Medications |
|---|---|
| Description | Number of subjects utilizing anti-hypertensive medications at 3 months. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 32 | 17 |
| Count of Participants [Participants] |
16
47.1%
|
9
52.9%
|
| Title | Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months |
|---|---|
| Description | Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 30 | 15 |
| Mean (Standard Deviation) [mmHg] |
-16.7
(13.6)
|
-9.5
(11.4)
|
| Title | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months |
|---|---|
| Description | Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 30 | 15 |
| Mean (Standard Deviation) [mmHg] |
-9.1
(8.3)
|
-5.5
(8.2)
|
| Title | Number of Subjects Utilizing Anti-hypertensive Medications |
|---|---|
| Description | Number of subjects utilizing anti-hypertensive medications at 6 months |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 33 | 17 |
| Count of Participants [Participants] |
26
76.5%
|
14
82.4%
|
| Title | Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure |
|---|---|
| Description | Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 29 | 12 |
| Mean (Standard Deviation) [mmHg] |
-18.2
(14.3)
|
-14.3
(8.4)
|
| Title | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure |
|---|---|
| Description | Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 29 | 12 |
| Mean (Standard Deviation) [mmHg] |
-11.0
(9.8)
|
-9.0
(5.7)
|
| Title | All-Cause Death |
|---|---|
| Description | Number of all causes of death through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number of Participants With Renal Failure |
|---|---|
| Description | Number of renal failure events through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
2
5.9%
|
0
0%
|
| Title | Number of Participants With Hypertensive Crisis |
|---|---|
| Description | Number of hypertensive crisis events through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
1
2.9%
|
0
0%
|
| Title | Mean Reduction in Average Office-based Systolic Blood Pressure |
|---|---|
| Description | Mean Reduction in Average office-based systolic blood pressure through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 30 | 11 |
| Mean (Standard Deviation) [mmHg] |
-19.7
(18.9)
|
-25.7
(21.2)
|
| Title | Mean Reduction in Average Office-based Diastolic Blood Pressure |
|---|---|
| Description | Mean Reduction in Office-based diastolic blood pressure through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 30 | 11 |
| Mean (Standard Deviation) [mmHg] |
-9.5
(10.3)
|
-9.8
(12.5)
|
| Title | Percent of Subjects at Target Blood Pressure |
|---|---|
| Description | Percent of subjects at target blood pressure through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment. |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 30 | 11 |
| Count of Participants [Participants] |
12
35.3%
|
5
29.4%
|
| Title | Congestive Heart Failure |
|---|---|
| Description | Number of subjects with congestive heart failure through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
1
2.9%
|
0
0%
|
| Title | Myocardial Infarction |
|---|---|
| Description | Number of subjects who experience myocardial infarction through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Stroke |
|---|---|
| Description | Number of subjects experiencing stroke through 24 months |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Denervation | Masked Procedure |
|---|---|---|
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography |
| Measure Participants | 34 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse events will be collected through 36 months from enrollment. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Enrollment terminated. No endpoint analysis conducted. | |||
| Arm/Group Title | Treatment Group | Masked Procedure - Control Group | ||
| Arm/Group Description | Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System) Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator Through 6 Months | Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography | ||
All Cause Mortality |
||||
| Treatment Group | Masked Procedure - Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/17 (0%) | ||
Serious Adverse Events |
||||
| Treatment Group | Masked Procedure - Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/34 (14.7%) | 5/17 (29.4%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Eye disorders | ||||
| Cataract | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Inguinal hernia | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hiatus hernia | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Infections and infestations | ||||
| Cellulitis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Diverticulitis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Osteomyelitis chronic | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Pneumonia | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Intentional overdose | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Road traffic accident | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Meningioma | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Psychiatric disorders | ||||
| Mental status changes | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Renal and urinary disorders | ||||
| Renal artery stenosis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Renal failure acute | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Pulmonary embolism | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Vascular disorders | ||||
| Accelerated hypertension | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Femoral artery occlusion | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hypertension | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Deep vein thrombosis | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Peripheral artery stenosis | 0/34 (0%) | 0 | 1/17 (5.9%) | 4 |
Other (Not Including Serious) Adverse Events |
||||
| Treatment Group | Masked Procedure - Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 27/34 (79.4%) | 13/17 (76.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Cardiac disorders | ||||
| Angina pectoris | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Palpitations | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Tachycardia | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Atrial fibrillation | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Tinnitus | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Vertigo | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Eye disorders | ||||
| Vision blurred | 2/34 (5.9%) | 2 | 0/17 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Nausea | 2/34 (5.9%) | 3 | 2/17 (11.8%) | 2 |
| Constipation | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Abdominal pain | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Diverticulum intestinal | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Food poisoning | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hiatus hernia | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Hypoaesthesia oral | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Toothache | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| General disorders | ||||
| Adverse drug reaction | 4/34 (11.8%) | 7 | 1/17 (5.9%) | 2 |
| Oedema peripheral | 3/34 (8.8%) | 3 | 1/17 (5.9%) | 1 |
| Non-cardiac chest pain | 1/34 (2.9%) | 1 | 2/17 (11.8%) | 2 |
| Fatigue | 2/34 (5.9%) | 2 | 0/17 (0%) | 0 |
| Asthenia | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Catheter site pain | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Immune system disorders | ||||
| Anaphylactic reaction | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Drug hypersensitivity | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Infections and infestations | ||||
| Bronchitis | 2/34 (5.9%) | 2 | 0/17 (0%) | 0 |
| Cellulitis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Upper respiratory tract infection | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Urinary tract infection | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Influenza | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Pharyngitis | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pulpitis dental | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Sinusitis | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Viral infection | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Localised infection | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Arthropod bite | 2/34 (5.9%) | 2 | 0/17 (0%) | 0 |
| Fall | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Procedural pain | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Rib fracture | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Vascular pseudoaneurysm | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Meniscus injury | 1/34 (2.9%) | 2 | 0/17 (0%) | 0 |
| Wound | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Investigations | ||||
| Blood aldosterone increased | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Blood pressure increased | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Carotid bruit | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Heart sounds abnormal | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Gout | 2/34 (5.9%) | 2 | 0/17 (0%) | 0 |
| Hypokalaemia | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/34 (2.9%) | 1 | 3/17 (17.6%) | 3 |
| Tendonitis | 0/34 (0%) | 0 | 2/17 (11.8%) | 2 |
| Joint swelling | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Muscular weakness | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Musculoskeletal pain | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Arthritis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 2/34 (5.9%) | 3 | 6/17 (35.3%) | 7 |
| Dizziness | 2/34 (5.9%) | 5 | 1/17 (5.9%) | 1 |
| Hypoaesthesia | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Mental impairment | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Paraesthesia | 1/34 (2.9%) | 2 | 0/17 (0%) | 0 |
| Neuropathy peripheral | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Psychiatric disorders | ||||
| Anxiety | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Renal and urinary disorders | ||||
| Renal artery stenosis | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Pollakiuria | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Renal artery dissection | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Renal cyst | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Renal failure chronic | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Nephrolithiasis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Erectile dysfunction | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/34 (2.9%) | 1 | 1/17 (5.9%) | 1 |
| Nasal congestion | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Pulmonary congestion | 0/34 (0%) | 0 | 1/17 (5.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Ecchymosis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Vascular disorders | ||||
| Hypertension | 11/34 (32.4%) | 13 | 4/17 (23.5%) | 5 |
| Arterial spasm | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
| Hypertensive crisis | 1/34 (2.9%) | 1 | 0/17 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Trial Manager |
|---|---|
| Organization | Boston Scientific |
| Phone | 970-294-4082 |
| nicole.kilburn@bsci.com |
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02392351
Other Study ID Numbers:
- S2333
First Posted:
Mar 19, 2015
Last Update Posted:
Feb 11, 2021
Last Verified:
Jan 1, 2021