TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

Not Applicable

Completed

• Conditions: Resistant Hypertension
• Interventions: Device: PARADISE percutaneous renal denervation

• Registration Number: NCT01789918
• Lead Sponsor: ReCor Medical, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-09
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Percutaneous renal denervation	PARADISE percutaneous renal denervation	PARADISE percutaneous renal denervation

Primary Outcome Measures

Name	Time	Method
Change from baseline in systolic blood pressure	12 months	Change from baseline in systolic blood pressure
Percentage of patients with device- or procedure-related adverse events	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in anti-hypertensive medication intake	12 months	Change from baseline in anti-hypertensive medication intake
Change from baseline in diastolic blood pressure	12 months	Change from baseline in diastolic blood pressure
Changes from baseline in pulse pressure and nocturnal dipping	12 months	Changes from baseline in pulse pressure and nocturnal dipping

Trial Locations

Locations (8)

Erasmus MC - Thoraxcenter; 🇳🇱 Rotterdam, Netherlands

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

CardioVasculäres Centrum; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Universitäts-Herzzentrum Freiburg • Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg/Saar, Germany

Universitätsklinikum Lübeck; 🇩🇪 Lübeck, Germany

Sahlgrenska Universitetssjukhuset; 🇸🇪 Göteborg, Sweden