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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022888
Receipt No. 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

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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
Email 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
Email nakayama@med.kobe-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

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
Email 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
cancel
Participant flow
cancel
Adverse events
o
Outcome measures
cancel
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026373

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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