UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053181 |
|---|---|
| Receipt number | R000060690 |
| Scientific Title | A Prospective Observational Study of the Effect of Drive Time on Anemia during Use of the JETSTREAM Catheter for Atherectomy Ablation Angioplasty |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/12/05 13:57:11 |
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Basic information
Public title
A Prospective Observational Study of the Effect of Drive Time on Anemia during Use of the JETSTREAM Catheter for Atherectomy Ablation Angioplasty
Acronym
A Prospective Observational Study of the Effect of Drive Time on Anemia during Use of the JETSTREAM Catheter for Atherectomy Ablation Angioplasty
Scientific Title
A Prospective Observational Study of the Effect of Drive Time on Anemia during Use of the JETSTREAM Catheter for Atherectomy Ablation Angioplasty
Scientific Title:Acronym
A Prospective Observational Study of the Effect of Drive Time on Anemia during Use of the JETSTREAM Catheter for Atherectomy Ablation Angioplasty
Region
| Japan |
Condition
Condition
lower extremity arterial disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively observe and study the relationship between JETSTREAM drive time and anemia progression in patients treated with JETSTREAM during EVT
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in hemoglobin levels before and after JETSTREAM treatment
Key secondary outcomes
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 scheduled for EVT using JETSTREAM for LEAD
2) Patients who are 20 years of age or older at the time of treatment
3) Patients who understand the treatment, the purpose of the study, and are able to give consent.
Key exclusion criteria
Patients undergoing combined surgical treatment at the time of EVT
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
TEL
09039981922
k722black@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
TEL
09039981922
Homepage URL
k722black@yahoo.co.jp
Sponsor or person
Institute
Hyogo Prefectural Awaji Medical Center
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
Hyogo Prefectural Awaji Medical Center
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
Tel
0799-22-1200
Awaji_hos@pref.hyogo.lg.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
| 2024 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In addition to patient background, the following data will be collected on patients who have undergone JETSTREAM for LEAD with consent
Preoperative examination
Peripheral arterial disease assessment ABI, Rutherford classification
Vital signs Blood pressure, pulse (sitting), able to walk
Medication history Antiplatelet and anticoagulant medications
Number of antihypertensive medications/ lipid improving medications/ oral diabetes medications/ insulin
Laboratory tests Red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit, creatinine, triglyceride levels, total cholesterol, HDL cholesterol, LDL cholesterol, HbA1c, CRP, haptoglobin, bilirubin, LDH, CK levels
EVT record
Date and time of EVT treatment Date of EVT treatment
Before treatment
Lesion type
-TASC2 classification (A/B/C/D)
-Target lesion site
-Presence or absence of CTO
PACSS classification (Grade 0-4)
-Presence of BK lesions
Blood tests
-Red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit level
Treatment details - JETSTREAM used (type, size)
Duration of each type of JETSTREAM used
Balloons used (type, diameter, length, maximal expansion pressure)
Approach site
Intravascular imaging device
Drainage in JETSTREAM suction bag
-Volume of drainage
-Hemoglobin level of drained fluid
Slow flow after treatment
Bleeding complications
Blood tests
-Red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit
Urinalysis findings in patients with auturia
-Bilirubinuria and hematuria
Perioperative bleeding complications
Blood tests
-Red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit, creatinine, CRP, haptoglobin, bilirubin, LDH, CK
QVA analysis
Before treatment Lesion site, lesion length (length, localized/tubular/diffuse), minimal lumen diameter, target lumen diameter (proximal lesion/distal lesion/average), lesion stenosis rate
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060690
