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Completed

NCT Number: NCT01789918

TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

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.

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Key information

Conditions

Resistant Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäts-Herzzentrum Freiburg • Bad Krozingen, Bad Krozingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PARADISE percutaneous renal denervation

Device

Intravascular ultrasound emission

Other names: ReCor Medical PARADISE

Primary outcomes

  1. Percentage of patients with device- or procedure-related adverse events

    Time frame: 12 months

    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

  2. Change from baseline in systolic blood pressure

    Time frame: 12 months

    Change from baseline in systolic blood pressure

Secondary outcomes

  1. Change from baseline in diastolic blood pressure

    Time frame: 12 months

    Change from baseline in diastolic blood pressure

  2. Change from baseline in anti-hypertensive medication intake

    Time frame: 12 months

    Change from baseline in anti-hypertensive medication intake

  3. Changes from baseline in pulse pressure and nocturnal dipping

    Time frame: 12 months

    Changes from baseline in pulse pressure and nocturnal dipping

Other outcomes

  1. Change from baseline in EQ-5D Quality of Life score

    Time frame: 12 months

    Change from baseline in EQ-5D Quality of Life score

  2. Change from baseline in cardiac function

    Time frame: 12 months

    Change from baseline in cardiac function

Sponsors and collaborators

Lead sponsor

ReCor Medical, Inc.

Industry

Registry information

Official study title

TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation

Acronym: ACHIEVE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2013
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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