Trials / Active Not Recruiting
Active Not RecruitingNCT03614260
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 225 (estimated)
- Sponsor
- ReCor Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Paradise Renal Denervation System | Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization. |
| PROCEDURE | Renal Angiogram | Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure. |
Timeline
- Start date
- 2018-12-14
- Primary completion
- 2022-12-21
- Completion
- 2027-07-01
- First posted
- 2018-08-03
- Last updated
- 2025-04-04
Locations
47 sites across 8 countries: United States, Belgium, France, Germany, Ireland, Netherlands, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03614260. Inclusion in this directory is not an endorsement.