OCT Evaluates the Effects of CTEPH Treated by Scoring Balloon

CTEPH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480137
• Other study ID #: 2022XMSB0000725
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Rui Xiang, Phd
• Phone: 18680790729
• Email: 10180788[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. PEA not available in patients with CTEPH

2. Patients assessed by a multidisciplinary panel as having a large risk-benefit ratio for PEA surgery

3. Patients with postoperative residual pulmonary hypertension after PEA

4. Patients with CTEPH not respond well to medical treatment

Exclusion Criteria:

1. Other cardiovascular diseases, such as Congenital heart disease, valvular disease, cardiomyopathy, aortic dissection, arteritis, arrhythmia, Severe heart failure

2. 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.

3. central-type chronic thromboembolic pulmonary hypertension

4. Other types of PAH except CTEPH

5. malignant tumor patients

6. severe renal dysfunction (GFR <30ml/min)

7. iodine contrast medium allergy

8. Gravida

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

Related Conditions & MeSH terms

• CTEPH

Intervention

Procedure:
• NSE scoring balloon and plain balloon angioplasty
Using NSE scoring balloon or plain balloon in BPA surgery.

Locations

Country	Name	City	State
China	the First Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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