REnAL denervatIon by ultraSound Transcatheter Emission

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension

NCT01756300

Hypertension, Renal

COMPLETED PHASE1

Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure

NCT00511407

Acute Renal Failure

COMPLETED PHASE2

Sevelamer Hydrochloride and Femoral and Carotid Intima Media Thickness Progression in End Stage Renal Disease

NCT01049815

End Stage Renal Disease Hemodialysis Intimal Media Thickness

COMPLETED NA

A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

NCT00863707

Kidney Diseases Coronary Artery Disease

COMPLETED PHASE4

Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

NCT06790498

Diabetic Kidney Disease Chronic Kidney Disease

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Resistant Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Percutaneous renal denervation

Group Type EXPERIMENTAL

PARADISE percutaneous renal denervation

Intervention Type DEVICE

Intravascular ultrasound emission

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PARADISE percutaneous renal denervation

Intravascular ultrasound emission

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ReCor Medical PARADISE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
* 18 years of age or older
* Negative pregnancy test for female patients of childbearing potential
* Willing and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria

* Secondary hypertension
* Main renal arteries length \< 20 mm
* Main renal arteries diameter \< 4 mm
* Renal artery stenosis
* Iliac/femoral artery stenosis precluding insertion of the catheter
* Allergy to contrast media
* Currently participating in the study of an investigational drug or device
* Hemodynamics abnormality
* Moderate to severe renal insufficiency

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No