NCT05480137

Brief Summary

Chronic thromboembolic pulmonary hypertension (CTEPH) is a disease of obstructive pulmonary artery remodelling as a consequence of major vessel thromboembolism. The diagnosis of CTEPH is based on findings obtained after at least 3 months of effective anticoagulation in order to discriminate this condition from subacute PE. These findings are mean pulmonary artery pressure ≥25mmHg with pulmonary artery wedge pressure ≤15 mmHg, mismatched perfusion defects on lung scan and specific diagnostic signs for CTEPH seen by multidetector CT angiography, MR imaging or conventional pulmonary cineangiography, such as ring-like stenoses, webs/slits and chronic total occlusions (pouch lesions or tapered lesions). Balloon pulmonary angioplasty (BPA) is a type of effective treatment for CTEPH. Plain balloon is usually used in BPA surgery,however，the efficacy and safety of NSE scoring balloon in BPA is not clear. Optical coherence tomography（OCT）as a good assessment methods has been reported. Our study aims to explore the efficacy and safty of NSE scoring balloon based on OCT in BPA .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 25, 2022

Last Update Submit

July 28, 2022

Conditions

CTEPH

Outcome Measures

Primary Outcomes (1)

  • PVR after BPA

    Mean pulmonary artery pressure (mPAP), mean pulmonary wedge pressure (mPCWP) and cardiac output （CO） will be combined to report pulmonary vascular resistance (PVR）in Unit Wood. Formula： PVR=（mPAP-mPCWP）/CO

    1-3 months after BPA

Study Arms (2)

plain balloon

OTHER

plain balloon is used in BPA

Procedure: NSE scoring balloon and plain balloon angioplasty

NSE scoring balloon

OTHER

NSE scoring balloon is used in BPA

Procedure: NSE scoring balloon and plain balloon angioplasty

Interventions

NSE scoring balloon and plain balloon angioplastyPROCEDURE

Using NSE scoring balloon or plain balloon in BPA surgery.

NSE scoring balloonplain balloon

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PEA not available in patients with CTEPH
  • Patients assessed by a multidisciplinary panel as having a large risk-benefit ratio for PEA surgery
  • Patients with postoperative residual pulmonary hypertension after PEA
  • Patients with CTEPH not respond well to medical treatment

You may not qualify if:

  • Other cardiovascular diseases, such as Congenital heart disease, valvular disease, cardiomyopathy, aortic dissection, arteritis, arrhythmia, Severe heart failure
  • Other diseases of the respiratory system, such as chronic obstructive pulmonary disease, asthma, pulmonary bronchial artery embolism, and other diseases, such as vasculitis, Pulmonary sarcoma, etc.
  • central-type chronic thromboembolic pulmonary hypertension
  • Other types of PAH except CTEPH
  • malignant tumor patients
  • severe renal dysfunction （GFR \<30ml/min）
  • iodine contrast medium allergy
  • Gravida
  • high risk of serious bleeding：Active bleeding，Acute stroke，Severe hepatic insufficiency (Child-Pugh C)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Study Officials

  • Rui Xiang, Phd

    First Affiliated Hospital of Chongqing Medical University

    STUDY CHAIR

Central Study Contacts

Rui Xiang, Phd

CONTACT

1868079072910180788@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 29, 2022

Study Start

August 30, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2023

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

All IPD will be shared with other researchers

Time Frame
After our study is published
Access Criteria
IPD shares with experienced and high-volume CTEPH centres.

Locations

CN(1)