TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

This study is currently recruiting participants.

Verified February 2013 by ReCor Medical, Inc.

Sponsor:

Information provided by (Responsible Party):

ReCor Medical, Inc.

ClinicalTrials.gov Identifier:

NCT01789918

First received: February 8, 2013

Last updated: NA

Last verified: February 2013

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 8, 2013

Last Updated Date

February 8, 2013

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of patients with device- or procedure-related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in systolic blood pressure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Change from baseline in diastolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in diastolic blood pressure
Change from baseline in anti-hypertensive medication intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in anti-hypertensive medication intake
Changes from baseline in pulse pressure and nocturnal dipping [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Changes from baseline in pulse pressure and nocturnal dipping

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Change from baseline in EQ-5D Quality of Life score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in EQ-5D Quality of Life score
Change from baseline in cardiac function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in cardiac function

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

Official Title ^ICMJE

TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation

Brief Summary

The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on fifty (50) eligible patients with a twelve month follow-up period.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Resistant Hypertension

Intervention ^ICMJE

Device: PARADISE percutaneous renal denervation

Intravascular ultrasound emission

Other Name: ReCor Medical PARADISE

Study Arm (s)

Experimental: Percutaneous renal denervation

PARADISE percutaneous renal denervation

Intervention: Device: PARADISE percutaneous renal denervation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Belgium, Germany, Netherlands, Sweden, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01789918

Other Study ID Numbers ^ICMJE

CLIN-0030-HT

Has Data Monitoring Committee

Responsible Party

ReCor Medical, Inc.

Study Sponsor ^ICMJE

ReCor Medical, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas Zeller, Professor

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Information Provided By

ReCor Medical, Inc.

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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