Back to resultsRenal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN (RADIUS-HTN)
Primary Purpose
Uncontrolled Hypertension, Renal Denervation, TransRadial
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Renal Denervation surgery
Sponsored by
About this trial
This is an interventional treatment trial for Uncontrolled Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patient ≥18 and ≤75 years old
- Persistent uncontrolled hypertension defined as Mean of three measurements systolic office >150 mmHg, mean diastolic >80 mmHg, corresponding ambulatory blood pressure mean ≥140 mmHg (24 hours daytime mean) despite prescription of 2 to 5 anti-hypertensive drugs including one ARB associated to one diuretic or Calcium Channel blocker
- Renal artery diameter ≥3 mm (to be assessed during the procedure)
- Patient eligible for TransFemoral Access and TransRadial Access
- Patient who understands the trial requirements and the treatment procedures and provides written informed consent
Exclusion Criteria:
- eGFR >45 mL/min/m²
- Prior renal artery intervention
- Prior renal transplant
- Presence of accessory artery (polar artery) supplying more than 20% of renal surface that cannot be treated (diameter <3 mm) during the procedure
- Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
- Patient currently participating in another investigational drug or device study
- Pregnant or breastfeeding women or those intending to become pregnant before the end of the follow-up
- Subjects under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TransRadial access
TransFemoral Access
Arm Description
Patients in this group are thus treated using a TRA approach
Patients in this group are thus treated using a TFA approach.
Outcomes
Primary Outcome Measures
Reduction of systolic office systolic blood pressure (OBP) at 3 months.
A routine OBP measurement is defined as the average of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room.
Secondary Outcome Measures
Procedural success
Number of participants with successful completion of the renal denervation procedure via the intended approach
Number of ablations per patient
Number of ablations performed during the procedure for each participants
Procedural duration
Lenght of the procedure
X-Ray exposure
Level of X-Ray exposure
Volume of contrast media
Volume of contrast media use during the procedure
Major vascular events
major hematoma, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, arterial thrombosis, dissection and perforation, distal embolization, femoral nerve injury, local infection and arterial avulsion
Office systolic blood pressure
3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)
Office diastolic blood pressure
3 readings at 1-minute intervals after a 5-minute resting period in the examination room
Ambulatory (24 h) blood pressure
Mean (mmHg)
Daytime (7:00 am to 10:00 pm) and nighttime (10:00 pm to 7:00 am) BP
Mean (mmHg)
Percentage of patients at target BP
Percentage of patient with mean systolic OBP <150 mmHg and min diastolic OBP < 80 mmHg
Office heart rate
BPM
Ambulatory heart rate
BPM
Home BP
3 measurements in the morning and evening
Home heart rate
3 measurements in the morning and evening
Renal function
change of estimated-Glomerular Filtration Rate (eGFR)
Renal artery safety
absence of renal re intervention, renal artery stenosis or dissection. This will be assesed during the follow-up by asking patients if he had some adverse events after the procedure. If yes, it will be asked to the patient to detailed and some documents about the event will be collected and adjudicated by a Clinical Event Committee
Changes in medication (DDD Defined Daily Doses)
Length of in hospital stay
Percentage of Vascular Access Site Complication (VASC)
Percentage of Cerebrovascular events
Percentage of Bleeding
Patient satisfaction
Assessed by the Medical Outcomes Study Short Form 36-item health status questionnaire (acute SF-36) and a series of procedure-specific questions
Full Information
NCT ID
NCT05234788
First Posted
January 6, 2022
Last Updated
February 1, 2022
Sponsor
Shanghai AngioCare Medical
1. Study Identification
Unique Protocol Identification Number
NCT05234788
Brief Title
Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
Acronym
RADIUS-HTN
Official Title
Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN:Non Inferiority Study Comparing Safety and Efficacy of Radio Frequency Renal Denervation Using Iberis Renal Denervation System Via Radial Access Compared With Femoral
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai AngioCare Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Non-inferiority, prospective, multi-center, post-market, randomized 1:1 study in patients with uncontrolled hypertension to compare the safety and efficacy of radio frequency renal denervation using Iberis Renal Denervation System via radial access compared with femoral access.
Detailed Description
Non-inferiority, prospective, multi-center, post-market, randomized 1:1 study. 90 patients with uncontrolled hypertension treated with 2 to 5 anti-hypertensive drugs including one Angiotensin Receptor Blocker (ARB) associated to one diuretic or Calcium Channel blocker.
12 sites will be selected in 3 countries (France, Germany and Monaco) to enroll 90 patients.
A parallel registry on radial approach only (patients who cannot be treated by femoral ) will have the same follow up.
Each patients will have two follow-ups:
at 3 months (90+14)
at 6 months (180+30)
The expected duration of the inclusion is 15 months. The estimated duration of the Study is 26 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension, Renal Denervation, TransRadial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TransRadial access
Arm Type
Experimental
Arm Description
Patients in this group are thus treated using a TRA approach
Arm Title
TransFemoral Access
Arm Type
Active Comparator
Arm Description
Patients in this group are thus treated using a TFA approach.
Intervention Type
Procedure
Intervention Name(s)
Renal Denervation surgery
Other Intervention Name(s)
RDN
Intervention Description
Renal Denervation surgery using TransRadial Access
Primary Outcome Measure Information:
Title
Reduction of systolic office systolic blood pressure (OBP) at 3 months.
Description
A routine OBP measurement is defined as the average of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Procedural success
Description
Number of participants with successful completion of the renal denervation procedure via the intended approach
Time Frame
Procedure
Title
Number of ablations per patient
Description
Number of ablations performed during the procedure for each participants
Time Frame
Procedure
Title
Procedural duration
Description
Lenght of the procedure
Time Frame
Procedure
Title
X-Ray exposure
Description
Level of X-Ray exposure
Time Frame
Procedure
Title
Volume of contrast media
Description
Volume of contrast media use during the procedure
Time Frame
Procedure
Title
Major vascular events
Description
major hematoma, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, arterial thrombosis, dissection and perforation, distal embolization, femoral nerve injury, local infection and arterial avulsion
Time Frame
Hospitalisation (at least 24hours after procedure)
Title
Office systolic blood pressure
Description
3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)
Time Frame
6 months
Title
Office diastolic blood pressure
Description
3 readings at 1-minute intervals after a 5-minute resting period in the examination room
Time Frame
3 months and 6 months
Title
Ambulatory (24 h) blood pressure
Description
Mean (mmHg)
Time Frame
3 months and 6 months
Title
Daytime (7:00 am to 10:00 pm) and nighttime (10:00 pm to 7:00 am) BP
Description
Mean (mmHg)
Time Frame
3 months and 6 months
Title
Percentage of patients at target BP
Description
Percentage of patient with mean systolic OBP <150 mmHg and min diastolic OBP < 80 mmHg
Time Frame
3 months and 6 months
Title
Office heart rate
Description
BPM
Time Frame
3 months and 6 months
Title
Ambulatory heart rate
Description
BPM
Time Frame
3 months and 6 months
Title
Home BP
Description
3 measurements in the morning and evening
Time Frame
7 days prior to baseline/randomization and before every follow-up
Title
Home heart rate
Description
3 measurements in the morning and evening
Time Frame
7 days prior to baseline/randomization and before every follow-up
Title
Renal function
Description
change of estimated-Glomerular Filtration Rate (eGFR)
Time Frame
3 months and 6 months
Title
Renal artery safety
Description
absence of renal re intervention, renal artery stenosis or dissection. This will be assesed during the follow-up by asking patients if he had some adverse events after the procedure. If yes, it will be asked to the patient to detailed and some documents about the event will be collected and adjudicated by a Clinical Event Committee
Time Frame
6 months
Title
Changes in medication (DDD Defined Daily Doses)
Time Frame
3 and 6 months
Title
Length of in hospital stay
Time Frame
Discharge (up to 48 hours)
Title
Percentage of Vascular Access Site Complication (VASC)
Time Frame
Discharge (up to 48 hours), 3 and 6 months
Title
Percentage of Cerebrovascular events
Time Frame
Discharge (up to 48 hours), 3 and 6 months
Title
Percentage of Bleeding
Time Frame
Discharge (up to 48 hours), 3 and 6 months
Title
Patient satisfaction
Description
Assessed by the Medical Outcomes Study Short Form 36-item health status questionnaire (acute SF-36) and a series of procedure-specific questions
Time Frame
Discharge (up to 48 hours) and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ≥18 and ≤75 years old
Persistent uncontrolled hypertension defined as Mean of three measurements systolic office >150 mmHg, mean diastolic >80 mmHg, corresponding ambulatory blood pressure mean ≥140 mmHg (24 hours daytime mean) despite prescription of 2 to 5 anti-hypertensive drugs including one ARB associated to one diuretic or Calcium Channel blocker
Renal artery diameter ≥3 mm (to be assessed during the procedure)
Patient eligible for TransFemoral Access and TransRadial Access
Patient who understands the trial requirements and the treatment procedures and provides written informed consent
Exclusion Criteria:
eGFR >45 mL/min/m²
Prior renal artery intervention
Prior renal transplant
Presence of accessory artery (polar artery) supplying more than 20% of renal surface that cannot be treated (diameter <3 mm) during the procedure
Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
Patient currently participating in another investigational drug or device study
Pregnant or breastfeeding women or those intending to become pregnant before the end of the follow-up
Subjects under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision
12. IPD Sharing Statement
Learn more about this trial
Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
We'll reach out to this number within 24 hrs