NCT01541865

Brief Summary

The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable hypertension

Geographic Reach
7 countries

24 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

February 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 16, 2015

Completed
Last Updated

November 25, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

February 21, 2012

Results QC Date

September 15, 2015

Last Update Submit

October 23, 2015

Conditions

Hypertension

Keywords

hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension

Outcome Measures

Primary Outcomes (2)

  • Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment

    Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .

    Baseline and 6 months

  • Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure

    Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.

    Baseline and 6 months

Secondary Outcomes (10)

  • Absence of Flow Limiting Stenosis in the Renal Artery

    6 months

  • Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery

    Duration of the procedure (average of 65 minutes)

  • Renal Artery Infarction or Embolus

    Duration of the procedure (average of 65 minutes)

  • Cerebrovascular Accident (CVA) at Time of Procedure

    Duration of the procedure (average of 65 minutes)

  • Myocardial Infarction at Time of Procedure

    Duration of the procedure (average of 65 minutes)

  • +5 more secondary outcomes

Study Arms (1)

Renal Denvervation

OTHER

All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.

Device: Renal Denervation

Interventions

Renal DenervationDEVICE

percutaneous renal denervation using the Vessix RF balloon catheter

Also known as: Vessix V2 Renal Denervation System
Renal Denvervation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have provided written informed consent;
  • Subjects who are ≥ 18 years and ≤ 75 years of age;
  • Subjects who have Systolic Blood Pressure (SBP) ≥ 160 mm Hg based on an average of three (3) office-based blood pressure readings (seated) measured according to protocol;
  • Subjects with ≥ 3 anti-hypertensive drugs at maximally tolerated doses with stable regimen for at least 2 weeks prior to enrollment
  • Subjects with a estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m\^2;
  • Suitable renal artery anatomy
  • Subjects who are willing and able to comply with all study procedures.

You may not qualify if:

  • Subjects with known/diagnosed secondary hypertension;
  • Subjects who are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure;
  • Subjects with known bleeding or hyper-coagulation disorders;
  • Subjects who have type 1 diabetes mellitus;
  • Subjects who have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques;
  • Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months;
  • Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;
  • Subjects who have an implantable cardioverter defibrillator, pacemaker, or clinically significant abnormal electrocardiogram
  • Subjects who have any serious medical condition, which in the opinion of the investigator, may adversely affect patient safety or the efficacy of the procedure in the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia);
  • Subjects who are pregnant, nursing or planning to become pregnant;
  • Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;
  • Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;
  • Subjects who, for any reason, may not be able to understand or comply with instructions;
  • Subjects who are contraindicated for intravascular contrast material;
  • Subjects who are currently taking estrogen or any estrogen-like compound.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

The Prince Charles Hospital, Cardiology Clinical Research Centre

Brisbane, Queensland, 4032, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Monash Cardiovascular Research Centre (Monash Heart)

Clayton, Victoria, 3168, Australia

Location

AKH Linz

Linz, 4020, Austria

Location

Salzburger Landeskliniken Universitats Krankenhaus

Salzburg, A-5020, Austria

Location

OLV Ziekenhuis

Aalst, Belgium

Location

Cliniques Universiaires Saint-Luc

Brussels, Belgium

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Clinic Pasteur

Toulouse, F-31076, France

Location

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Kardiologische Praxis Main-Taunus

Bad Soden/Taunus, 65812, Germany

Location

Vascular Center Berlin, Ev. Königin Elisabeth Hospital

Berlin, 10365, Germany

Location

St. Vincenz Krankenhaus Abt. Kardiologie

Essen, 45141, Germany

Location

CardioVascular Center, Sankt Katharinen Krakenhaus

Frankfurt, 60389, Germany

Location

Hamburg University Cardiovascular Center

Hamburg, 22527, Germany

Location

Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology

Homburg/Saar, D-66421, Germany

Location

University Leipzig

Leipzig, 04109, Germany

Location

German Heart Center Munich

Münich, 80636, Germany

Location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

Erasmus Medical Center-Thorax Center

Rotterdam, 3015CE, Netherlands

Location

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

Location

Mercy Angiography Unit Ltd

Auckland, 1023, New Zealand

Location

University Hospital of Geneva, Cardiology Center

Geneva, 1211, Switzerland

Location

Switzerland University Hospital Clinic for Cardiology

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01.

    PMID: 25452197RESULT

  • Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.

    PMID: 25186534RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Angela Schutt, Clinical Trial Manager
Organization
Boston Scientific
angela.schutt@bsci.com
763-494-2166

Study Officials

  • Horst Sievert, M.D.

    CardioVascular Center Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 21, 2012

First Posted

March 1, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2013

Study Completion

June 1, 2015

Last Updated

November 25, 2015

Results First Posted

October 16, 2015

Record last verified: 2015-10

Locations

AU(5)NL(2)NZ(2)DE(9)BE(2)FR(2)CH(2)