A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension. - A randomized controlled study to evaluate the efficacy and safety of pressure-wire-guided balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022888

Enrollment

Registered

2016-12-01

Start date

2016-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CTEPH (chronic thromboembolic pulmonary hypertension)

Interventions

Group A:pressure-wire-guided balloon pulmonary angioplasty Group B:non pressure-wire-guided balloon pulmonary angioplasty

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Frequency of reperfusion pulmonary injury	—

Secondary

Measure	Time frame
Pulmonary hemodynamics (after final balloon pulmonary angioplasty)	—

Countries

Japan

Contacts

Public ContactKazuhiko Nakayama

Kobe University Graduate School of Medicine, Kobe, Japan Division of Cardiovascular Medicine, Department of Internal Medicine

nakayama@med.kobe-u.ac.jp078-382-5846

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026