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
  Purpose

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.


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

Resource links provided by NLM:


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


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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
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
Belgium
Universiteit Antwerpen Recruiting
Antwerpen, Belgium, 2020
Contact: Johan Bosmans, Professor    + 32 3 265 32 11    johan.bosmans@ua.ac.be   
Principal Investigator: Johan Bosmans, Professor         
Germany
Universitäts-Herzzentrum Freiburg • Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Zeller, Professor    +49 7633 402-2431    Thomas.Zeller@universitaets-herzzentrum.de   
Principal Investigator: Thomas Zeller, Professor         
CardioVasculäres Centrum Recruiting
Frankfurt, Germany, 60389
Contact: Horst Sievert, Professor    069 4603 1340    horstsievertmd@aol.com   
Principal Investigator: Horst Sievert, Professor         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, Professor    (0 40) 18 18-82 66 98    kuckkh@aol.com   
Principal Investigator: Karl-Heinz Kuck, Professor         
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany, 66424
Contact: Michael Böhm, Professor    06841 / 16 - 0    Michael.Boehm@uniklinikum-saarland.de   
Principal Investigator: Michael Böhm, Professor         
Universitätsklinikum Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Joachim Weil, Professor    0451 500 - 2501    joachim.weil@uk-sh.de   
Principal Investigator: Joachim Weil, Professor         
Netherlands
Erasmus MC - Thoraxcenter Recruiting
Rotterdam, Netherlands, 3015
Contact: Joost Daemen, Doctor    +31 (0)10-46 35 288    joostdaemen@me.com   
Principal Investigator: Joost Daemen, Doctor         
Sweden
Sahlgrenska Universitetssjukhuset Recruiting
Göteborg, Sweden, 413 45
Contact: Bert Andersson, Doctor    +46 31 342 7537    Bert.Andersson@wlab.gu.se   
Principal Investigator: Bert Andersson, Doctor         
Switzerland
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Stephan Windecker, Professor    +41 (0)31 632 21 11    Stephan.Windecker@insel.ch   
Principal Investigator: Stephan Windecker, Professor         
Sponsors and Collaborators
ReCor Medical, Inc.
Investigators
Principal Investigator: Thomas Zeller, Professor Universitäts-Herzzentrum Freiburg • Bad Krozingen
  More Information

No publications provided

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: February 8, 2013
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission

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 28, 2014