A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT02690909
• Date of registration: 19/02/2016
• Prospective Registration: Yes
• Primary sponsor: Renal Dynamics GmbH
• Public title: A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
• Scientific title: A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
• Date of first enrolment: April 2016
• Target sample size: 55
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02690909
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Belgium, Germany, Hungary, Ireland, Israel, Poland, Russian Federation, Serbia

Contacts

• Name: Erifyli Kalloudi

• Name: Felix Mahfoud, MD
• Affiliation: Saarland University Medical Center Homburg, Germany

Key inclusion & exclusion criteria

Inclusion criteria:

1. Patient has established hypertension (diagnosed =12 months prior to screening) and is
on a guideline based stable drug regimen (= 4 weeks), consisting of =3
anti-hypertensive medications of different classes including a diuretic;

2. Office systolic blood pressure >150 mmHg;

3. Patient has (under directly observed therapy) average daytime systolic blood pressure
values > 140 mmHg by 24h ambulatory blood pressure monitoring;

4. Patient is = 18 and = 75 years of age at time of consent;

5. Patient must be able and willing to comply with the required follow-up schedule;

6. Patient must be able and willing to provide written informed consent;

Exclusion criteria:

1. Patient has known significant reno-vascular abnormalities such as renal artery
stenosis > 30%;

2. Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure < 90
mmHg;

3. Evidence or history of secondary hypertension, other than sleep apnea syndrome;

4. Patient has a history of prior renal angioplasty, renal denervation, indwelling renal
stents, and/or abdominal aortic stent graft placement;

5. Patient has significant valvular heart disease;

6. Patient has known coagulation abnormalities;

7. Patient life expectancy is < 12 months, as estimated by the study Investigator;

8. Patient is participating in another clinical study, which is before its primary
endpoint and/or has the potential to impact his/her hypertension management
(pharmaceutical / device);

9. Patient is pregnant, nursing, or of childbearing potential and is not using adequate
contraceptive methods;

10. Patient has active systemic infection;

11. Patient has small <4.0 mm in diameter, large >6.5 mm in diameter or short <20.0 mm in
length, multiple main, or highly tortuous renal arteries;

12. Patient has impaired renal function with an estimated GFR <45 mL/min per 1.73 m2
using the Modification of Diet in Renal Disease (MDRD) formula;

13. Patient had a renal transplant or is awaiting a renal transplant;

14. Patient has a known intolerance for x-ray contrast agent that cannot be adequately
controlled with pre-medication;

15. Any medical condition as estimated by the Study Investigator that may harm patient or
jeopardize study participation, the interpretation of study results or may impede the
ability to obtain informed consent (e.g., mental condition);



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension Resistant to Conventional Therapy

Intervention(s)

Device: Redy™ Renal Denervation System

Primary Outcome(s)

Device-related adverse events at 1-month follow-up post treatment [Time Frame: 1-month post treatment]

Secondary Outcome(s)

Device-related Adverse Events at 3 and 6 months follow-up post treatment [Time Frame: 3 and 6 months post treatment]

Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months [Time Frame: 3 months post treatment]

Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment [Time Frame: 1, 3 and 6 months post treatment]

Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment [Time Frame: 1, 3 and 6 months post treatment]

Peri-procedural Adverse Events at 1-month follow-up post treatment [Time Frame: 1-month post treatment]

Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment [Time Frame: 1, 3 and 6 months post treatment]

Secondary ID(s)

RD1501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biosensors Europe SA

AmeRuss Clinical Trials LLC, USA

Physio-Logic Ltd. Israel