This trial is active, not recruiting.

Condition resistant hypertension
Treatment paradise percutaneous renal denervation
Sponsor ReCor Medical, Inc.
Start date February 2013
End date December 2016
Trial size 96 participants
Trial identifier NCT01789918, CLIN-0030-HT


The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to include up to one hundred (100) eligible patients as defined within the clinical investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
PARADISE percutaneous renal denervation
paradise percutaneous renal denervation ReCor Medical PARADISE
Intravascular ultrasound emission

Primary Outcomes

Percentage of patients with device- or procedure-related adverse events
time frame: 12 months
Change from baseline in systolic blood pressure
time frame: 12 months

Secondary Outcomes

Change from baseline in diastolic blood pressure
time frame: 12 months
Change from baseline in anti-hypertensive medication intake
time frame: 12 months
Changes from baseline in pulse pressure and nocturnal dipping
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Untreated allergy to contrast media - Currently participating in the study of an investigational drug or device - Moderate to severe renal insufficiency

Additional Information

Official title TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation
Principal investigator Thomas Zeller, Professor
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by ReCor Medical, Inc..