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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027676
Receipt No. R000031702
Scientific Title Multicenter study of renal denervation system TCD-16164(feasibility study)
Date of disclosure of the study information 2017/06/08
Last modified on 2018/12/12

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Basic information
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
Condition Resistant hypertension and uncontrolled hypertension with difficulty of additional antihypertensive medication
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Change in mean 24hr SBP at 3 months assessed by ABPM
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Last 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

Public contact
1st 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

Sponsor
Institute TERUMO CORPORATION
Institute
Department

Funding Source
Organization TERUMO CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 07 Day
Last modified on
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031702

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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