UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057574 |
|---|---|
| Receipt number | R000065685 |
| Scientific Title | A prospective multicenter registry for investigating outcomes of intravascular ultrasound (IVUS) guided tip detection method in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2025/04/10 11:06:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective multicenter registry for investigating outcomes of
intravascular ultrasound (IVUS) guided tip detection method in chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Acronym
Tip detection CTO PCI Registry
Scientific Title
A prospective multicenter registry for investigating outcomes of
intravascular ultrasound (IVUS) guided tip detection method in chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Scientific Title:Acronym
Tip detection CTO PCI Registry
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of tip detection methods in CTO-PCI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of the TD method in CTO-PCI, Proportion of patients who successfully crossed the wire through the CTO lesion with the tip detection method and obtained good recanalization without contrast delay in the final angiography
Key secondary outcomes
Efficacy secondary endpoints
-Procedure information and results of tip detection method (Intraplaque tracking or ADR selection criteria, device selection, procedure time, false lumen crossing distance, complications)
-Evaluation of CTO-PCI procedure, radiation exposure, fluoroscopy time, contrast medium usage
-Restenosis rate by coronary angiography during follow-up period (9 months) and revascularization rate during clinical follow-up period
Safety secondary endpoints
-Incidence of MACCE during hospitalization (all-cause death, cardiovascular death, myocardial infarction, revascularization, cerebral infarction)
-MACCE during follow-up (9 months)
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. Patients aged 20 years or older at the time of providing informed consent and who underwent PCI for chronic total occlusions that meet the following criteria for treatment with PCI:
A) TIMI 0 (no continuous antegrade blood flow).
B) Occlusion period > 3 months or unknown
C) CTO in a major coronary artery (Seg 1-3, 5-8, 11, 13) or a coronary artery branch with significant perfusion area equivalent to a major coronary artery (Seg 4, 9/10,12)
2.Patients who are able and willing to visit the hospital for necessary follow-up visits and examinations
Key exclusion criteria
1. Patients who are unable to give consent for the use of their information and have requested it.
2. Patients who are unable to receive antiplatelet therapy
3. Patients who are deemed by the investigator or co-investigator to be ineligible to participate in this study for any other reason.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsunori, Ryohei |
| Middle name | |
| Last name | Okamura, Yoshikawa |
Organization
Sakurabashi Watanabe Advanced Healthcare Hospital, Sanda City Hospital
Division name
Cardiovascular Center
Zip code
530-0005, 669-1321
Address
4-3-51 Nakanoshima, Kita Ward, Osaka, 530-0005, Japan. 3-1-1 Keyakidai,Sanda-shi, 669-1321,Hyogo, Japan
TEL
06-6676-8215
a_okamura@watanabe-hsp.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro, Kota |
| Middle name | |
| Last name | Yamasaki, Tanaka |
Organization
Sakurabashi Watanabe Advanced Healthcare Hospital
Division name
Cardiovascular Center
Zip code
530-0005
Address
4-3-51 Nakanoshima, Kita Ward, Osaka, 530-0005, Japan
TEL
06-6676-8215
Homepage URL
doanditwillbedone77@gmail.com
Sponsor or person
Institute
Sakurabashi Watanabe Advanced Healthcare Hospital
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Site Management Organization, Sakurabashi Watanabe Advanced Healthcare Hospital
Address
4-3-51 Nakanoshima, Kita Ward, Osaka, 530-0005, Japan
Tel
06-6676-8215
chiken@watanabe-hsp.or.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
桜橋渡辺未来医療病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tip detection CTO PCI Registry is a observational study to determine the success rate of the tip detection technique for Chronic Total Occlusion (CTO) lesion guided by intravascular ultrasound (IVUS) during PCI procedure.
Management information
Registered date
| 2025 | Year | 04 | Month | 10 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065685
