UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027676 |
|---|---|
| Receipt number | 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 | 2023/12/12 09:22:58 |
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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
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
kkario@jichi.ac.jp
Public contact
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
Keisuke_ozawa@terumo.co.jp
Sponsor or person
Institute
TERUMO CORPORATION
Institute
Department
Personal name
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
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
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
Other related information
Management 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
