UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026977 |
|---|---|
| Receipt number | R000030934 |
| Scientific Title | Endovascular therapy using TruePathTM chronic total occlusion device, a multicenter prospective study |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2022/10/17 22:28:10 |
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Basic information
Public title
Endovascular therapy using TruePathTM chronic total occlusion device, a multicenter prospective study
Acronym
Endovascular therapy using TruePathTM chronic total occlusion device, a multicenter prospective study
Scientific Title
Endovascular therapy using TruePathTM chronic total occlusion device, a multicenter prospective study
Scientific Title:Acronym
Endovascular therapy using TruePathTM chronic total occlusion device, a multicenter prospective study
Region
| Japan |
Condition
Condition
Infrainguinal symptomatic peripheral artery disease with chronic total occlusion
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluate the safety and efficacy of using TruePathTM CTO device for infrainguinal symptomatic peripheral artery disease with chronic total occlusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure success (TruePath CTO device cross the target occlusion through to the true distal lumen)
Key secondary outcomes
Complication
Proportion of true lumen using IVUS analysis
Procedure time, device using time, fluoroscopy time, dose
Improvement of Rutherford category
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Informed consent was done
2)Infrainguinal peripheral artery disease with chronic total occulusion(included in-stent occulusion)
3)Atherosclerotic peripheral artery disease (Rutherford category 2-5)
4)ABI value was less than 0.9 or if the value was more than 0.9, the ischemia of lower limb was confirmed by other modalities.
5)Meet the criteria of EVT
6)More than 20 years old
7)Agreement the clinical follow up.(after procedure, 6 months, 12 months)
Key exclusion criteria
1)Less than 20 years old
2)Pregnancy
3)Stenotc lesions
4)Common femoral artery lesion (If EVT are going to perform for Iliac lesions simultaneously, it allows the study).
5)Planed other clinical study
6)Planed surgical bypass, below/above the knee amputation within 30 days
7)Poor life expectancy
8)Difficulty of antiplatelet therapy, anticoagrant therapy
9)Severe dementia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Tomoi |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
802-8555
Address
Kokura-kita-ku, Asano 3-2-1 Kitakyushu city
TEL
093-511-2000
mbxtg263@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Tomoi |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
802-8555
Address
Kokura-kita-ku, Asano 3-2-1 Kitakyushu city
TEL
093-511-2000
Homepage URL
mbxtg263@ybb.ne.jp
Sponsor or person
Institute
Kokura Memorial Hospital, Cardiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kokura Memrial Hospital
Address
3-2-1 Asano, Kokurakita-ku Kitakyushu
Tel
093-511-2000
mbxtg263@ybb.ne.jp
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
小倉記念病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
J Endovasc Ther. 2020 Feb;27(1):69-76.
Publication of results
Published
Result
URL related to results and publications
J Endovasc Ther. 2020 Feb;27(1):69-76.
Number of participants that the trial has enrolled
143
Results
Complete success was achieved in 82 (56.2%) lesions; any success (complete plus assisted) was documented in 117 (80.1%) lesions.
Results date posted
| 2022 | Year | 10 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
mean age 75 years 101 men
Participant flow
prospective observational study
Adverse events
Four (3%) perioperative device-related complications were observed.
Outcome measures
Complete success
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Lesion length (TASC-II)
Type of chronic total occlusion
Calcification
Management information
Registered date
| 2017 | Year | 04 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030934
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/10/15 | 2017.04.18_TRUMP_study.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/10/15 | 2017.04.18_TRUMP_study.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/10/15 | 2017.04.18_TRUMP_study.docx |
