CTEPHNCT05480137
OCT Evaluates the Effects of CTEPH Treated by Scoring Balloon
A study testing NSE scoring balloon and plain balloon angioplasty in people with CTEPH, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CTEPH
- What is being tested?
- NSE scoring balloon and plain balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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）
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- iodine contrast medium allergy
- Gravida
- high risk of serious bleeding：Active bleeding，Acute stroke，Severe hepatic insufficiency (Child-Pugh C)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Wei Huang, Doctor, 86 13638309211, weihuangcq@gmail.com
About this study
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
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 .
Read the 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.
- Conditions
- CTEPH
- Being tested
- NSE scoring balloon and plain balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSE scoring balloon and plain balloon angioplastyProcedure or surgery
Using NSE scoring balloon or plain balloon in BPA surgery.
| Study group | Role | What they receive |
|---|---|---|
| plain balloon | Other | plain balloon is used in BPA Receives: Procedure: NSE scoring balloon and plain balloon angioplasty |
| NSE scoring balloon | Other | NSE scoring balloon is used in BPA Receives: Procedure: NSE scoring balloon and plain balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-3 months after BPA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start30 Aug 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTEPHStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Huang, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Rui Xiang, Phd, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480137
- Sponsor's protocol ID
- 2022XMSB0000725
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05480137
- Acronym / sponsor ID
- 2022XMSB0000725
- Conditions
- CTEPH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plain balloon | Other | Procedure: NSE scoring balloon and plain balloon angioplastyplain balloon is used in BPA |
| NSE scoring balloon | Other | Procedure: NSE scoring balloon and plain balloon angioplastyNSE scoring balloon is used in BPA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSE scoring balloon and plain balloon angioplastyUsing NSE scoring balloon or plain balloon in BPA surgery. | Procedure or surgery | NSE scoring balloon, plain balloon |
Primary outcome
PVR after BPA
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: Yes. All IPD will be shared with other researchers
Related trials for CTEPH
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Xiang, Phd study chair
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSE scoring balloon and plain balloon angioplasty in people with CTEPH, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Xiang, Phd (18680790729, 10180788@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVR after BPA (time frame: 1-3 months after BPA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.