TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

Resistant Hypertension Clinical Trial

— ACHIEVE  

Official title:

TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789918
• Other study ID #: CLIN-0030-HT
• Status: Completed
• Phase: N/A
• Start date: January 9, 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2018
• Source: ReCor Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Device:
• PARADISE percutaneous renal denervation
Intravascular ultrasound emission

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Freiburg • Bad Krozingen	Bad Krozingen
Germany	Universitätsklinikum Essen	Essen
Germany	CardioVasculäres Centrum	Frankfurt
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Universitätsklinikum Lübeck	Lübeck
Netherlands	Erasmus MC - Thoraxcenter	Rotterdam
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
ReCor Medical, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in EQ-5D Quality of Life score	Change from baseline in EQ-5D Quality of Life score	12 months
Other	Change from baseline in cardiac function	Change from baseline in cardiac function	12 months
Primary	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
Primary	Change from baseline in systolic blood pressure	Change from baseline in systolic blood pressure	12 months
Secondary	Change from baseline in diastolic blood pressure	Change from baseline in diastolic blood pressure	12 months
Secondary	Change from baseline in anti-hypertensive medication intake	Change from baseline in anti-hypertensive medication intake	12 months
Secondary	Changes from baseline in pulse pressure and nocturnal dipping	Changes from baseline in pulse pressure and nocturnal dipping	12 months