TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

ReCor Medical, Inc.96 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Resistant Hypertension

Interventions

PARADISE percutaneous renal denervationDEVICE

Intravascular ultrasound emission

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Bad Krozingen, Germany

Universitätsklinikum Essen

Essen, Germany

CardioVasculäres Centrum

Frankfurt, Germany

Asklepios Klinik St. Georg

Hamburg, Germany

Outcomes

Primary Outcomes

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

Time frame: 12 months

Change from baseline in systolic blood pressure

Time frame: 12 months

Secondary Outcomes

Change from baseline in diastolic blood pressure

Time frame: 12 months

Change from baseline in anti-hypertensive medication intake

Time frame: 12 months

Changes from baseline in pulse pressure and nocturnal dipping

Time frame: 12 months

Data from ClinicalTrials.gov

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