UMIN-CTR Clinical Trial

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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