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Recruitment status
Unique ID issued by UMIN UMIN000001572
Receipt No. R000001896
Scientific Title Percutaneous Transluminal Pulmonary Angioplasty for Patients with Chronic Pulomonary Thromboembolism
Date of disclosure of the study information 2009/01/12
Last modified on 2008/12/13

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Basic information
Public title Percutaneous Transluminal Pulmonary Angioplasty for Patients with Chronic Pulomonary Thromboembolism
Acronym Percutaneous Transluminal Pulmonary Angioplasty for Patients with Chronic Pulomonary Thromboembolism
Scientific Title Percutaneous Transluminal Pulmonary Angioplasty for Patients with Chronic Pulomonary Thromboembolism
Scientific Title:Acronym Percutaneous Transluminal Pulmonary Angioplasty for Patients with Chronic Pulomonary Thromboembolism
Region
Japan

Condition
Condition pulmonary arterial hypertension due to chronic pulmonary thromboembolism
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy of percutaneous transluminal pulmonary angioplasty for patients with chronic pulmonary thromboembolism
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes symptom (NYHA classfication), 6 minutes walk test, right heart catheterization, computed tomography for evaluation of pulmonary artery, ventilation-perfusion scan, echocardiography
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 percutaneous transluminal pulmonary angioplasty
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 patients with chronic pulmonary thromboembolism who are refractory to other therapy and maladjustive for pulmonary endoarterectomy
Key exclusion criteria patients who can not express subjective symptoms, whose objective improvement cannot be evaluated, who have systemic hypertension, who have bleeding complications, who have critical liver dysfunction, who are under pregnancy or breast-feeding, and who have critical left heart disease
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Satoh
Organization Keio University School of Medicine
Division name Medical Education Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Medical Education Center
Zip code
Address
TEL
Homepage URL
Email m.kataoka@cpnet.med.keio.ac.jp

Sponsor
Institute Medical Education Center, Keio University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 01 Month 12 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
Date of protocol fixation
2008 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 13 Day
Last modified on
2008 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001896

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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