Trial Outcomes & Findings for Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (NCT NCT01541865)

NCT ID: NCT01541865

Last Updated: 2015-11-25

Results Overview

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. .

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 146 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2015-11-25

Participant Flow

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.

Participant milestones

Measure	Renal Denervation All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Study STARTED	146
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	Renal Denervation All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Study Lost to Follow-up	11
Overall Study Withdrawal by Subject	9
Overall Study Adverse Event	1
Overall Study Protocol Violation	1

Baseline Characteristics

Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

Baseline characteristics by cohort

Measure	Renal Denervation n=146 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Age, Continuous	58.1 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants
Race/Ethnicity, Customized White	135 participants n=5 Participants
Race/Ethnicity, Customized Black, Asian, Other	11 participants n=5 Participants
Region of Enrollment New Zealand	21 participants n=5 Participants
Region of Enrollment Austria	13 participants n=5 Participants
Region of Enrollment Netherlands	5 participants n=5 Participants
Region of Enrollment Belgium	17 participants n=5 Participants
Region of Enrollment Australia	31 participants n=5 Participants
Region of Enrollment France	8 participants n=5 Participants
Region of Enrollment Switzerland	2 participants n=5 Participants
Region of Enrollment Germany	49 participants n=5 Participants
Type 2 Diabetes Type 2 Diabetes	41 participants n=5 Participants
Type 2 Diabetes Non-Diabetic	105 participants n=5 Participants
Coronary Artery Disease Coronary Artery Disease	55 participants n=5 Participants
Coronary Artery Disease No Coronary Artery Disease	91 participants n=5 Participants
Congestive Heart Failure Congestive Heart Failure	3 participants n=5 Participants
Congestive Heart Failure No Congestive Heart Failure	143 participants n=5 Participants
Dyslipidemia Dyslipidemia	85 participants n=5 Participants
Dyslipidemia No Dyslipidemia	61 participants n=5 Participants
Baseline Systolic Blood Pressure	182.4 mm Hg STANDARD_DEVIATION 18.4 • n=5 Participants
Baseline Diastolic Blood Pressure	100.2 mm Hg STANDARD_DEVIATION 14.0 • n=5 Participants
Heart Rate	71.7 beats/min STANDARD_DEVIATION 14.8 • n=5 Participants
Estimated glomerular filtration rate (eGFR)	82.7 mL/min/1.73m^2 STANDARD_DEVIATION 22.5 • n=5 Participants
Serum Creatinine	82.0 micromol/L STANDARD_DEVIATION 20.0 • n=5 Participants
Number of Antihypertensive Medications per Patient	4.8 Antihypertensive Medications per Patient STANDARD_DEVIATION 1.5 • n=5 Participants
Antihypertensive Medications Subjects on greater than or equal to 5 medications	79 participants n=5 Participants
Antihypertensive Medications Subjects on 4 medications	38 participants n=5 Participants
Antihypertensive Medications Subjects on 3 medications	26 participants n=5 Participants
Antihypertensive Medications Subjects on 2 medications	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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. .

Outcome measures

Measure	Renal Denervation n=143 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
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
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

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Renal Denervation n=70 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
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
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

SECONDARY outcome

Timeframe: 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.

Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound

Outcome measures

Measure	Renal Denervation n=143 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Absence of Flow Limiting Stenosis in the Renal Artery	139 participants w/o flow limiting stenosis

SECONDARY outcome

Timeframe: Duration of the procedure (average of 65 minutes)

Outcome measures

Measure	Renal Denervation n=146 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery	0 participants

SECONDARY outcome

Timeframe: Duration of the procedure (average of 65 minutes)

Outcome measures

Measure	Renal Denervation n=146 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Renal Artery Infarction or Embolus	0 participants

SECONDARY outcome

Timeframe: Duration of the procedure (average of 65 minutes)

Outcome measures

Measure	Renal Denervation n=146 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Cerebrovascular Accident (CVA) at Time of Procedure	0 participants

SECONDARY outcome

Timeframe: Duration of the procedure (average of 65 minutes)

Outcome measures

Measure	Renal Denervation n=146 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Myocardial Infarction at Time of Procedure	0 participants

SECONDARY outcome

Timeframe: Duration of the procedure (average of 65 minutes)

Outcome measures

Measure	Renal Denervation n=146 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Sudden Cardiac Death at Time of Procedure	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Renal Denervation n=124 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Angiographically-documented Renal Stenosis Requiring an Intervention	1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Renal Denervation n=124 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Chronic Symptomatic Orthostatic Hypotension	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Renal Denervation n=124 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)	10 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Renal Denervation n=121 Participants All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%	16 participants

Adverse Events

Renal Denervation

Serious events: 69 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Renal Denervation n=146 participants at risk All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Surgical and medical procedures Access Site Infection	1.4% 2/146 • Number of events 2 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Clot or Thrombus Formation	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Hematoma	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Other Vascular - Stenosis	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Pseudoaneurysm	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Other - Flank Pain	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Other - Digestive (vomiting)	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Other - Hypertensive Crisis	2.7% 4/146 • Number of events 5 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Other Cardiac - Hypertensive episode	0.68% 1/146 • Number of events 2 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Acute Occlusion/Vessel Closure	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Stent Required	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Vascular disorders Other Vascular - Carotid Stenosis	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Renal and urinary disorders Renal Insufficiency	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Renal and urinary disorders Renal Failure	2.1% 3/146 • Number of events 3 • Adverse events were collect through the 2 year follow up visit.
Cardiac disorders Myocardial Infarction	2.7% 4/146 • Number of events 6 • Adverse events were collect through the 2 year follow up visit.
Vascular disorders Other Renal - Renal Calcification	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Respiratory, thoracic and mediastinal disorders Other Pulmonary	4.8% 7/146 • Number of events 7 • Adverse events were collect through the 2 year follow up visit.
Infections and infestations Other Infectious/Inflammatory	6.2% 9/146 • Number of events 10 • Adverse events were collect through the 2 year follow up visit.
Vascular disorders Stroke	1.4% 2/146 • Number of events 2 • Adverse events were collect through the 2 year follow up visit.
Cardiac disorders Congestive Heart Failure	3.4% 5/146 • Number of events 8 • Adverse events were collect through the 2 year follow up visit.
General disorders Other Neurological	1.4% 2/146 • Number of events 2 • Adverse events were collect through the 2 year follow up visit.
Reproductive system and breast disorders Unanticipated Adverse Events - Prolapsis Uteri	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Cardiac disorders Other Cardiac - Chest Pain/Angina	4.8% 7/146 • Number of events 8 • Adverse events were collect through the 2 year follow up visit.
Renal and urinary disorders Other - Hypertension	8.9% 13/146 • Number of events 21 • Adverse events were collect through the 2 year follow up visit.
Cardiac disorders Other Cardiac - Fibrillation	3.4% 5/146 • Number of events 5 • Adverse events were collect through the 2 year follow up visit.
Cardiac disorders Other Cardiac - Tachycardia	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Infections and infestations Other - Inflammation/Infection	6.8% 10/146 • Number of events 14 • Adverse events were collect through the 2 year follow up visit.
General disorders Other - Thoracic/Abdominal Pain	2.7% 4/146 • Number of events 4 • Adverse events were collect through the 2 year follow up visit.
General disorders Other - Hernia	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Gastrointestinal disorders Other - Gastrointestinal/Rectal	4.1% 6/146 • Number of events 7 • Adverse events were collect through the 2 year follow up visit.
Musculoskeletal and connective tissue disorders Other - Skeletal/Connective Tissue	8.9% 13/146 • Number of events 19 • Adverse events were collect through the 2 year follow up visit.
General disorders Other - Deconditioning post medical illness	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
General disorders Other - Dementia	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Metabolism and nutrition disorders Other - Diabetes	3.4% 5/146 • Number of events 6 • Adverse events were collect through the 2 year follow up visit.
Surgical and medical procedures Other - Elective Surgery	1.4% 2/146 • Number of events 2 • Adverse events were collect through the 2 year follow up visit.
Reproductive system and breast disorders Other - Priapismus	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Vascular disorders Other - Limb oedema/ Ulceration	1.4% 2/146 • Number of events 2 • Adverse events were collect through the 2 year follow up visit.
Vascular disorders Other - Coronary Sub-Occlusion	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
General disorders Other - Nausea	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
General disorders Other - Overdose	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Reproductive system and breast disorders Other - Prostate Carcinoma	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Respiratory, thoracic and mediastinal disorders Other - Sleep Apnoea	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.
Psychiatric disorders Other - Suicide Ideation	0.68% 1/146 • Number of events 1 • Adverse events were collect through the 2 year follow up visit.

Other adverse events

Measure	Renal Denervation n=146 participants at risk All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Skin and subcutaneous tissue disorders Access Site Complications	13.7% 20/146 • Number of events 22 • Adverse events were collect through the 2 year follow up visit.
General disorders Pain	15.8% 23/146 • Number of events 23 • Adverse events were collect through the 2 year follow up visit.
Skin and subcutaneous tissue disorders Hematoma	12.3% 18/146 • Number of events 19 • Adverse events were collect through the 2 year follow up visit.
General disorders Anaesthesia Related - Nausea/Vomiting	8.2% 12/146 • Number of events 14 • Adverse events were collect through the 2 year follow up visit.
Renal and urinary disorders Reduced Kidney Function	6.2% 9/146 • Number of events 9 • Adverse events were collect through the 2 year follow up visit.
General disorders Dizziness	11.0% 16/146 • Number of events 18 • Adverse events were collect through the 2 year follow up visit.
General disorders Hypertension	9.6% 14/146 • Number of events 14 • Adverse events were collect through the 2 year follow up visit.

Additional Information

Angela Schutt, Clinical Trial Manager

Boston Scientific

Phone: 763-494-2166

Email: angela.schutt@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place