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OCT Evaluates the Effects of CTEPH Treated by Scoring Balloon

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05480137
Enrollment
46
Registered
2022-07-29
Start date
2020-08-30
Completion date
2023-08-31
Last updated
2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CTEPH

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 .

Detailed 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.

Interventions

PROCEDURENSE scoring balloon and plain balloon angioplasty

Using NSE scoring balloon or plain balloon in BPA surgery.

Sponsors

First Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
PVR after BPA1-3 months after BPAMean 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

Countries

China

Contacts

Primary ContactRui Xiang, Phd
10180788@qq.com18680790729

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026