TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

Study Overview
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Brief Summary
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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.

Official Title
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TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation

Conditions
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Resistant Hypertension

Intervention / Treatment
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* Device: PARADISE percutaneous renal denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous renal denervation<br>PARADISE percutaneous renal denervation | Device: PARADISE percutaneous renal denervation<br>* Intravascular ultrasound emission<br>* Other names: ReCor Medical PARADISE;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Blood pressure, Renal denervation