Resistant Hypertension
Conditions
Keywords
Hypertension, Blood pressure, Renal denervation
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.
Interventions
Intravascular ultrasound emission
Sponsors
ReCor Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change from baseline in systolic blood pressure | 12 months | Change from baseline in systolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in pulse pressure and nocturnal dipping | 12 months | Changes from baseline in pulse pressure and nocturnal dipping |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in EQ-5D Quality of Life score | 12 months | Change from baseline in EQ-5D Quality of Life score |
| Change from baseline in cardiac function | 12 months | Change from baseline in cardiac function |
Countries
Germany, Netherlands, Sweden
Outcome results
None listed