Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

Uncontrolled Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05234788
• Other study ID #: BIO-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2022
• Source: Shanghai AngioCare Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient =18 and =75 years old

2. 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

3. Renal artery diameter =3 mm (to be assessed during the procedure)

4. Patient eligible for TransFemoral Access and TransRadial Access

5. Patient who understands the trial requirements and the treatment procedures and provides written informed consent

Exclusion Criteria:

1. eGFR >45 mL/min/m²

2. Prior renal artery intervention

3. Prior renal transplant

4. Presence of accessory artery (polar artery) supplying more than 20% of renal surface that cannot be treated (diameter <3 mm) during the procedure

5. Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent

6. Patient currently participating in another investigational drug or device study

7. Pregnant or breastfeeding women or those intending to become pregnant before the end of the follow-up

8. Subjects under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision

Related Conditions & MeSH terms

• Hypertension
• Renal Denervation
• TransRadial
• Uncontrolled Hypertension

Intervention

Procedure:
• Renal Denervation surgery
Renal Denervation surgery using TransRadial Access

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai AngioCare Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Procedural success	Number of participants with successful completion of the renal denervation procedure via the intended approach	Procedure
Secondary	Number of ablations per patient	Number of ablations performed during the procedure for each participants	Procedure
Secondary	Procedural duration	Lenght of the procedure	Procedure
Secondary	X-Ray exposure	Level of X-Ray exposure	Procedure
Secondary	Volume of contrast media	Volume of contrast media use during the procedure	Procedure
Secondary	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	Hospitalisation (at least 24hours after procedure)
Secondary	Office systolic blood pressure	3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)	6 months
Secondary	Office diastolic blood pressure	3 readings at 1-minute intervals after a 5-minute resting period in the examination room	3 months and 6 months
Secondary	Ambulatory (24 h) blood pressure	Mean (mmHg)	3 months and 6 months
Secondary	Daytime (7:00 am to 10:00 pm) and nighttime (10:00 pm to 7:00 am) BP	Mean (mmHg)	3 months and 6 months
Secondary	Percentage of patients at target BP	Percentage of patient with mean systolic OBP <150 mmHg and min diastolic OBP < 80 mmHg	3 months and 6 months
Secondary	Office heart rate	BPM	3 months and 6 months
Secondary	Ambulatory heart rate	BPM	3 months and 6 months
Secondary	Home BP	3 measurements in the morning and evening	7 days prior to baseline/randomization and before every follow-up
Secondary	Home heart rate	3 measurements in the morning and evening	7 days prior to baseline/randomization and before every follow-up
Secondary	Renal function	change of estimated-Glomerular Filtration Rate (eGFR)	3 months and 6 months
Secondary	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	6 months
Secondary	Changes in medication (DDD Defined Daily Doses)		3 and 6 months
Secondary	Length of in hospital stay		Discharge (up to 48 hours)
Secondary	Percentage of Vascular Access Site Complication (VASC)		Discharge (up to 48 hours), 3 and 6 months
Secondary	Percentage of Cerebrovascular events		Discharge (up to 48 hours), 3 and 6 months
Secondary	Percentage of Bleeding		Discharge (up to 48 hours), 3 and 6 months
Secondary	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	Discharge (up to 48 hours) and 3 months