TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE) (ACHIEVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01789918
First received: February 8, 2013
Last updated: April 4, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Resistant Hypertension
Device: PARADISE percutaneous renal denervation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation

Further study details as provided by ReCor Medical, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Enrollment: 96
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Percutaneous renal denervation
PARADISE percutaneous renal denervation
Device: PARADISE percutaneous renal denervation
Intravascular ultrasound emission
Other Name: ReCor Medical PARADISE

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789918

Locations
Germany
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Bad Krozingen, Germany, 79189
Universitätsklinikum Essen
Essen, Germany, 45147
CardioVasculäres Centrum
Frankfurt, Germany, 60389
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66424
Universitätsklinikum Lübeck
Lübeck, Germany, 23538
Netherlands
Erasmus MC - Thoraxcenter
Rotterdam, Netherlands, 3015
Sweden
Sahlgrenska Universitetssjukhuset
Göteborg, Sweden, 413 45
Sponsors and Collaborators
ReCor Medical, Inc.
Investigators
Principal Investigator: Thomas Zeller, Professor Universitäts-Herzzentrum Freiburg • Bad Krozingen
  More Information

Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT01789918     History of Changes
Other Study ID Numbers: CLIN-0030-HT 
Study First Received: February 8, 2013
Last Updated: April 4, 2016
Health Authority: Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)
Sweden: Regional Ethical Review Board

Keywords provided by ReCor Medical, Inc.:
Hypertension
Blood pressure
Renal denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2016