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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02295683
Other study ID # T124E2
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2014
Est. completion date September 4, 2017

Study information

Verified date October 2019
Source Terumo Europe N.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.


Description:

This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system.

This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension.

A minimum of 30 patients will be enrolled in Europe


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date September 4, 2017
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18 years or minimum age as required by local regulations.

- Patient has been thoroughly informed about this registry and signed Informed Consent Form.

- Patient with true resistant hypertension defined as:

- Office systolic BP higher than 160 or 150mmHg in case of type 2 diabetes

- Ambulatory BP with average BP>130mmHg or mean daytime>135mmHg in more than 70% of the measurements.

- Patients should be on stable hypertension therapy for at least 8 weeks before procedure, including spironolactone if they are supposed to be respondent as indicated by the specialized center/excellence unit on hypertension.

Exclusion Criteria:

- Previous renal artery intervention (balloon angioplasty or stenting).

- Evidence of renal artery atherosclerosis (defined as a renal artery stenosis >50%).

- Main renal arteries of less than 4mm diameter or less than 20mm in length.

- Presence of multiple main renal arteries in either kidney.

- Estimated glomerular filtration rate <45ml/min per 1,73m2

- Recent myocardial infarction, unstable angina pectoris or cerebrovascular accident within the past 3-6 months.

- False resistant hypertension (pseudo resistance) by using 24h ambulatory BP monitoring (ABPM).

- Secondary arterial hypertension.

- Pregnancy.

- There is another pathological process with well-known life expectancy of less than 5 years.

- Patient unable to do correct FU.

- Unable to take correct ambulatory BP.

- Primary hyperaldosteronism.

- Known lack of adherence to medical treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Renal Denervation


Locations

Country Name City State
Serbia Clinical Center of Serbia Belgrade
Spain Hospital Galdakao Galdakao

Sponsors (1)

Lead Sponsor Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Serbia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Pressure (BP) Measurements Office BP; Ambulatory BP; Home BP Up to 5 year FU
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