TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

R

ReCor Medical

Status

Completed

Conditions

Resistant Hypertension

Treatments

Device: PARADISE percutaneous renal denervation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01789918
CLIN-0030-HT

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

96 participants in 1 patient group

Percutaneous renal denervation
Experimental group
Description:
PARADISE percutaneous renal denervation
Treatment:
Device: PARADISE percutaneous renal denervation

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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