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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
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 |
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 |
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Condition | ||
Condition | pulmonary arterial hypertension due to chronic pulmonary thromboembolism | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Organization | Keio University School of Medicine | ||||||
Division name | Medical Education Center | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo | ||||||
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Public contact | |||||||
Name of contact person |
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Organization | Keio University School of Medicine | ||||||
Division name | Medical Education Center | ||||||
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TEL | |||||||
Homepage URL | |||||||
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |