TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by ReCor Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01789918
First received: February 8, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted

February 8, 2013
February 8, 2013
February 2013
February 2015   (final data collection date for primary outcome measure)
  • Percentage of patients with device- or procedure-related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Anticipated adverse events include:

    • Access site and access-related vascular injury
    • Renal artery complications, including: stenosis, aneurysm, dissection, and perforation
    • Renal complications, including: renal infarction, acute kidney injury, and renal failure
    • Arterial and venous thromboembolic events, including: myocardial infarction, stroke or transient ischemic attack, pulmonary embolism, and deep vein thrombosis
    • Systemic effects, including: allergic reaction and infection
  • Change from baseline in systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in systolic blood pressure
Same as current
No Changes Posted
  • Change from baseline in diastolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in diastolic blood pressure
  • Change from baseline in anti-hypertensive medication intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in anti-hypertensive medication intake
  • Changes from baseline in pulse pressure and nocturnal dipping [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes from baseline in pulse pressure and nocturnal dipping
Same as current
  • Change from baseline in EQ-5D Quality of Life score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in EQ-5D Quality of Life score
  • Change from baseline in cardiac function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in cardiac function
Same as current
 
TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)
TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation

The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on fifty (50) eligible patients with a twelve month follow-up period.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resistant Hypertension
Device: PARADISE percutaneous renal denervation
Intravascular ultrasound emission
Other Name: ReCor Medical PARADISE
Experimental: Percutaneous renal denervation
PARADISE percutaneous renal denervation
Intervention: Device: PARADISE percutaneous renal denervation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Belgium,   Germany,   Netherlands,   Sweden,   Switzerland
 
NCT01789918
CLIN-0030-HT
No
ReCor Medical, Inc.
ReCor Medical, Inc.
Not Provided
Principal Investigator: Thomas Zeller, Professor Universitäts-Herzzentrum Freiburg • Bad Krozingen
ReCor Medical, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP