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Safety and Efficacy of Balloon Pulmonary Angioplasty in China

NCT ID: NCT04206852

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-11

Study Completion Date

2028-05-11

Brief Summary

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Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).

The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.

Detailed Description

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This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA.

we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.

Conditions

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Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Balloon pulmonary angioplasty

Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Intervention Type PROCEDURE

Other Intervention Names

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BPA

Eligibility Criteria

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Inclusion Criteria

1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
3. Not amenable to pulmonary endarterectomy
4. Willing to provide informed consent

Exclusion Criteria

1. Patients unwilling or unable to provide written consent for participation in the study.
2. Impossible to follow up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Pulmonary Vascular Disease Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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center of pulmonary vascular disease, Fuwai hospital

Beijing, , China

Site Status RECRUITING

Chinese Academy of Medical Sciences Fuwai hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihong Liu, doctor

Role: CONTACT

Phone: 86-010-88396589

Email: [email protected]

Facility Contacts

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Zhihong Liu, doctor

Role: primary

Zhao zhihui, MD

Role: primary

Yang Tao, MD

Role: backup

Other Identifiers

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BPA registry

Identifier Type: -

Identifier Source: org_study_id