Clinical Study of Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2023-04-30

Brief Summary

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Chronic thromboembolic pulmonary hypertension (CTEPH) is the fourth group of pulmonary hypertension (PH) according to clinical classification. Pulmonary endarterectomy（PEA) is the preferred treatment for patients with CTEPH, however, PEA has its limitations, it only applies to the thrombi in the main, lobar, or segmental pulmonary arteries for patients with CTEPH, and the postoperative residual PH is found to be of high percentage. With the development of interventional techniques, balloon pulmonary angioplasty (BPA) has been used to treat chronic thrombotic pulmonary hypertension (CTEPH) with favorable results and has been identified as an effective and safe treatment for technically inoperable CTEPH. Balloon pulmonary angioplasty (BPA) has been accepted as a therapeutic strategy in accordance with the 2015 ESC/ESR guidelines, especially for patients with technically inoperable, an unfavorable risk-to-benefit ratio of the PEA. This study was a single-center prospective study that collects 3 time points data (before BPA, after final BPA, and follow-up ) to verify long-term safety and efficacy of BPA, as well as comparing the efficacy with targeted medical therapy, evaluating the complications of BPA, the survival of patients, and the postoperative quality of life.

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Detailed Description

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Conditions

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Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ballon pulmonary angioplasty

Ballon pulmonary angioplasty(BPA) is a stepwise procedure requiring several separate sessions. The interval of a series of BPA is one month. In a series of BPA, there are 2 sessions, which are repeated at a 2-week interval. BPA is performed primarily on one side of the lung in the first session, then after 2 weeks, performed on the other side of the lung. In each session, the fluoroscopy time or the amount contrast are less than 60min and 200ml, respectively.

Group Type OTHER

Ballon pulmonary angioplasty

Intervention Type PROCEDURE

Percutaneous vascular access for BPA is via the femoral vein using Seldinger technique. A 5Fr sheath is inserted into the vein, through which a 6Fr long introducer sheath is advanced into the pulmonary artery. Subsequently, a 6Fr guiding catheter is advanced into the pulmonary artery being treated. Generally, selective pulmonary angiography should be performed to evaluate lesion feature before BPA. Then a 0.014-inch guidewire is used to cross the lesion, a balloon catheter of an appropriate diameter is selected to dilate the lesion.

Interventions

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Ballon pulmonary angioplasty

Percutaneous vascular access for BPA is via the femoral vein using Seldinger technique. A 5Fr sheath is inserted into the vein, through which a 6Fr long introducer sheath is advanced into the pulmonary artery. Subsequently, a 6Fr guiding catheter is advanced into the pulmonary artery being treated. Generally, selective pulmonary angiography should be performed to evaluate lesion feature before BPA. Then a 0.014-inch guidewire is used to cross the lesion, a balloon catheter of an appropriate diameter is selected to dilate the lesion.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* technically inoperable for PEA in patients with CTEPH
* unfavorable risk/benefit ratio for PEA
* residual or recurrent PH after PEA
* aged over 18 years old

Exclusion Criteria

* other groups of PH except for CTEPH
* severe renal insufficiency(eGFR\<30ml/min·1.73mˆ2)
* severe infectious diseases
* severe hemorrhagic tendency
* severe anaphylaxis of contrast
* pregnancy and lactation
* expected survival time is less than half a year due to tumor or other disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Li Xuyan

Deputy Director of Respiratory and Critical Care Medicine,Beijing Institute of Respiratory Medicine, Beijing Chaoyang Hospital, Capital Medical University

Responsibility Role SPONSOR_INVESTIGATOR