UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047292 |
|---|---|
| Receipt number | R000053574 |
| Scientific Title | The significance of OptiCal FrEquency DomAin ImagiNg Findings for Predicting the Patency in Femoropopliteal Lesions Treated with Drug Coated Balloon : A Prospective Multicenter Study |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2024/03/26 09:13:09 |
* 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
The significance of OptiCal FrEquency DomAin ImagiNg Findings for Predicting the Patency in Femoropopliteal Lesions Treated with Drug Coated Balloon : A Prospective Multicenter Study
Acronym
OCEAN-DCB study
Scientific Title
The significance of OptiCal FrEquency DomAin ImagiNg Findings for Predicting the Patency in Femoropopliteal Lesions Treated with Drug Coated Balloon : A Prospective Multicenter Study
Scientific Title:Acronym
OCEAN-DCB study
Region
| Japan |
Condition
Condition
Arteriosclerosis obliterans
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively observe and clarify the mechanism of restenosis and the factors on OFDI that affect primary patency rate after treatment with drug-eluting balloons by evaluating the presence or absence of primary patency rate at 12 months in patients with atherosclerosis obliterans who underwent endovascular treatment with drug-eluting balloons under the guidance of optical frequency domain imaging for stenosis or occlusive lesions in the femoropopliteal artery territory
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary patency
Key secondary outcomes
At 12 months after treatment
1) Avoidance rate of restenosis assessed by echocardiography
2) Clinically driven TLR (target lesion revascularization) rate
3) Clinically driven target vessel revascularization (TLR) rate
4) Surgical revascularization rate
5) Incidence of acute thrombotic occlusion
6) Incidence of major lower extremity amputations (amputations central to the ankle joint)
7) Major adverse limb event (MALE [major adverse limb event]: any re-intervention or major amputation) rate
8) Rutherfurd classification
9) Adverse event rate
(1) All deaths, (2) deaths from cardiovascular disease, (3) presence of stroke/systemic embolism, (4) hospitalization for cardiac disease, (5) presence of intracranial hemorrhage
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 with atherosclerosis obliterans who have undergone OFDI-guided EVT using DCB on a standby basis for lesions in the femoral-patellar artery territory
2) Patients who are 20 years of age or older at the time of consent.
3) Patients who understand the treatment and purpose of the study and are able to give consent
Key exclusion criteria
1) Patients who are terminally ill and expected to live less than one year
2) Patients with acute lower limb ischemia or acute thrombosis
3) In-stent stenosis or occlusive lesions
4) Critically ill ischemic limb with suspected Rutherford Category 6 or extensive infection
5) Anastomotic lesions after bypass surgery
6) Patients who have difficulty continuing antiplatelet therapy (e.g., patients with planned surgical procedures requiring antiplatelet drug withdrawal within one month)
7) Patients who are or may be pregnant or breastfeeding
8) Patients who have or may have hypersensitivity to drug-eluting balloons, paclitaxel or its structural analogs, additives, or contrast media
9) Other patients who are judged inappropriate for inclusion by the study investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825846
taka02222003@gmail.com
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
567
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
09051218725
Homepage URL
taka02222003@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe university hospital Clinical and Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
0783826669
kansatsu@med.kobe-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
TBD
Management information
Registered date
| 2022 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053574
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
