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

Study Overview

• Status: Completed
• Conditions: Resistant Hypertension
• Intervention / Treatment: Device: PARADISE percutaneous renal denervation

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg • Bad Krozingen
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Frankfurt, Germany, 60389
    • CardioVasculäres Centrum
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Homburg/Saar, Germany, 66424
    • Universitätsklinikum des Saarlandes
  • Lübeck, Germany, 23538
    • Universitätsklinikum Lübeck
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus MC - Thoraxcenter
• Sweden
  • Göteborg, Sweden, 413 45
    • Sahlgrenska Universitetssjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous renal denervation; PARADISE percutaneous renal denervation	Device: PARADISE percutaneous renal denervation; Intravascular ultrasound emission; Other Names: ReCor Medical PARADISE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with device- or procedure-related adverse events	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	12 months
Change from baseline in systolic blood pressure	Change from baseline in systolic blood pressure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in diastolic blood pressure	Change from baseline in diastolic blood pressure	12 months
Change from baseline in anti-hypertensive medication intake	Change from baseline in anti-hypertensive medication intake	12 months
Changes from baseline in pulse pressure and nocturnal dipping	Changes from baseline in pulse pressure and nocturnal dipping	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in EQ-5D Quality of Life score	Change from baseline in EQ-5D Quality of Life score	12 months
Change from baseline in cardiac function	Change from baseline in cardiac function	12 months

Collaborators and Investigators

• Sponsor: ReCor Medical, Inc.
• Investigators: Principal Investigator: Thomas Zeller, Professor, Universitäts-Herzzentrum Freiburg • Bad Krozingen

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Blood pressure; Renal denervation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CLIN-0030-HT