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临床试验/NCT05480137
NCT05480137Unknown不适用

The Efficacy of Scoring Balloon Angioplasty in the Treatment of Chronic Thromboembolic Pulmonary Hypertension Based on Optical Coherence Tomography:A Single-center Randomized Controlled

First Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年8月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
46
试验地点
1
主要终点
PVR after BPA

研究概览

简要总结

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 .

详细描述

After right heart catheterization,BPA procedures are performed via femoral vein approach. 8-Fr sheath is inserted into the vein and 6-Fr guiding cathater was advanced to the main pulmonary artery through the 8-Fr guiding catheter using a 0.035-inch wire. We select a branch of the pulmonary artery by a 6-Fr guiding catheter (JR4.0). Pulmonary angiography is performed manually using half contrast medium diluted with saline. A 0.014-inch guidewire (Sion) is crossed under the pulmonary angiography, and OCT (Fig.1: Types of lesions) is used for the detection of Lumen diameter (mm), Intimal thickness (mm), Intimal area (mm2), Intimal thickness/lumen diameter, Intimal area/lumen area, which are defined as short diameter assessed by OCT. The balloon size, the expansion pressure and the choice of scoring balloon or plain balloon angioplasty are at the discretion of the operator. Balloon-to-vessel (B/V) ratio is defined as the balloon diameter divided by vessel diameter assessed with OCT (1:0.7-1). Pulmonary arteries with an inner diameter of less than 4mm detected by OCT were selected for BPA performance. Scoring balloon and plain balloon are used in half of pulmonary lesions respectively., use the Plain balloon was used to predilate, If the vascular Lesion is a completely occlusive or the scoring balloon cannot pass through vessels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • high risk of serious bleeding:Active bleeding,Acute stroke,Severe hepatic insufficiency (Child-Pugh C)

结局指标

主要结局

PVR after BPA

时间窗: 1-3 months 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

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Huang

Professor

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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