UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022888 |
|---|---|
| Receipt number | R000026373 |
| Scientific Title | A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2019/05/15 17:51:36 |
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Basic information
Public title
A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.
Acronym
A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.
Scientific Title
A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.
Scientific Title:Acronym
A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.
Region
| Japan |
Condition
Condition
CTEPH (chronic thromboembolic pulmonary hypertension)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if pressure-wire-guided balloon pulmonary angioplasty (BPA) reduces the frequency of reperfusion pulmonary injury for establishing effective and safe BPA strategy for chronic thromboembolic pulmonary hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of reperfusion pulmonary injury
Key secondary outcomes
Pulmonary hemodynamics (after final balloon pulmonary angioplasty)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A:pressure-wire-guided balloon pulmonary angioplasty
Interventions/Control_2
Group B:non pressure-wire-guided balloon pulmonary angioplasty
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)Dignosis of CTEPH.
2)Mean pulmonary artery pressure is more than 25mmHg, or more than class II of the WHO functional classification.
3)There are lesions targeted by balloon pulmonary angioplasty detected by pulmonary angiography.
4)Patients who can understand the study and provid written informed consent.
5)Patients who are older than or equal to 20 years old when providing their written consent.
Key exclusion criteria
1)Patients with uncontrollable heart failure
2)Patients managed by noninvasive positive pressure ventilation or mechanical ventilator.
3)Patients who can not provide informed consent.
4)Patients can not recieve anticoagulant therapy.
5)Female during pregnancy or breast-feeding
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakayama |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-2, Kusunoki, Chuo, Kobe, 650-0017, Japan
TEL
078-382-5846
nakayama@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakayama |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-2, Kusunoki, Chuo, Kobe, 650-0017, Japan
TEL
078-382-5846
Homepage URL
nakayama@med.kobe-u.ac.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
Division of Cardiovascular Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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, Chuo, Kobe, 650-0017, Japan
Tel
078-382-6669
chiken@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
神戸大学病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
cancel
Publication of results
Unpublished
Result
URL related to results and publications
cancel
Number of participants that the trial has enrolled
10
Results
cancel
Results date posted
| 2019 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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Participant flow
cancel
Adverse events
o
Outcome measures
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Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026373
