UMIN-CTR Clinical Trial

Public title

Multicenter study of renal denervation system TCD-16164(feasibility study)

Acronym

Multicenter study of TCD-16164(feasibility study)

Scientific Title

Multicenter study of renal denervation system TCD-16164(feasibility study)

Scientific Title:Acronym

Multicenter study of TCD-16164(feasibility study)

Region

Japan

Condition

Resistant hypertension and uncontrolled hypertension with difficulty of additional antihypertensive medication

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the efficacy and safety of renal denervation system TCD-16164

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in mean 24hr SBP at 3 months assessed by ABPM

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Advance the catheter to the target treatment location in the renal artery. Ablate both right and left renal arteries.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

More than 20 and less than 75 years
Patients who are able to understand the informed consent in the study and provide written informed consent to participate to the study
Patients taking three or four antihypertensive drugs of different classes or patients taking two antihypertensive drugs of different classes if it is difficult to treat with additional antihypertensive medications.
Patients who meet all of the following criteria for automated office blood pressure (AOBP)
Systolic BP: 140 mmHg or more
Diastolic BP: 90 mmHg or more
Patients who meet following criteria for mean 24hr BP assessed by ABPM (systolic) with a range between 135 mmHg and 180 mmHg
Female patients agree to use effective form of contraception until 36 months post procedure.

Key exclusion criteria

Patients who are considered to be insufficient in terms of improvement in lifestyle and review of antihypertensive therapy.
Patients who have poor adherence to medication.
Patients who have received balloon angioplasty, stenting or renal denervation in the renal artery.
Patients with a solitary kidney.
Patients with eGFR of less than 40 mL/min/1.73 m2.
Patients with a history of cardiac infarction, unstable angina or cerebrovascular disorder within 3 months before the procedure.
Patients with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus.
Patients having orthostatic hypotension
Patients with secondary hypertension except for those derived from obstructive sleep apnea syndrome.
Patients who lead a life where day and night are reversed.
Patients with implanted ICD or CRT-D.
Patients having conditions contraindicated to drugs using during intervention
Patients who regularly use nonsteroidal anti-inflammatory drugs.
Patient with renal artery stenosis with the rate of stenosis of 50% or over.
Patients without the renal artery with a diameter between 3 mm and 8 mm.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kazuomi Kario

Organization

Jichi Medical University Hospital

Division name

Cardiology

Zip code

Address

Yakushiji 3311-1, Shimotsuke, Tochigi 329-0428, Japan

TEL

0285-44-2111

Email

kkario@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	Keisuke Ozawa

Organization

TERUMO CORPORATION

Division name

Clinical Development Department

Zip code

Address

49F Tokyo Operacitytower, Nishishinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-6742-8244

Homepage URL

Email

Keisuke_ozawa@terumo.co.jp

Institute

TERUMO CORPORATION

Institute

Department

Personal name

Organization

TERUMO CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

12

Month

20

Day

Date of IRB

2017

Year

04

Month

21

Day

Anticipated trial start date

2017

Year

09

Month

06

Day

Last follow-up date

2022

Year

08

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

07

Day

Last modified on

2023

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031702