NCT01789918

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

February 8, 2013

Last Update Submit

July 5, 2018

Conditions

Resistant Hypertension

Keywords

HypertensionBlood pressureRenal denervation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change from baseline in diastolic blood pressure

    12 months

  • Change from baseline in anti-hypertensive medication intake

    12 months

  • Changes from baseline in pulse pressure and nocturnal dipping

    12 months

Other Outcomes (2)

  • Change from baseline in EQ-5D Quality of Life score

    12 months

  • Change from baseline in cardiac function

    12 months

Study Arms (1)

Percutaneous renal denervation

EXPERIMENTAL

PARADISE percutaneous renal denervation

Device: PARADISE percutaneous renal denervation

Interventions

PARADISE percutaneous renal denervationDEVICE

Intravascular ultrasound emission

Also known as: ReCor Medical PARADISE
Percutaneous renal denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

CardioVasculäres Centrum

Frankfurt, 60389, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66424, Germany

Location

Universitätsklinikum Lübeck

Lübeck, 23538, Germany

Location

Erasmus MC - Thoraxcenter

Rotterdam, 3015, Netherlands

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas Zeller, Professor

    Universitäts-Herzzentrum Freiburg • Bad Krozingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 12, 2013

Study Start

January 9, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

SE(1)DE(6)NL(1)