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

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 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

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

Value
https://center6.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