Aortic Dissection AneurysmNCT06062524
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
A study testing Aorta Vascular Plug System in people with Aortic Dissection Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 3 sites in China.
Trial summary
A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection Aneurysm
- What is being tested?
- Aorta Vascular Plug System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesChina
- Study dates
- 24 Oct 2023to 31 May 2026
- 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
- Patients aged 18 to 80 years old, no gender limitation;
- The patient was diagnosed with a dissecting aneurysm of the descending thoracic aorta after the repair of the main artery dissection, and the treatment indications were one of the following:
- Aortic dissection aneurysm diameter ≥ 5.5cm
- The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year
- Symptoms associated with dissection progression, such as chest and back pain
- The diameter of false lumen approximately 1 cm superiorly to the celiac trunk ≤40 mm
- Appropriate anatomical conditions were assessed by imaging to allow the adjustable bend conveyor to enter the pseudolumen through tears of the iliac artery, subrenal aorta, or renal artery levels.
- Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.
Who cannot join
- Aortic rupture;
- Continuous malperfusion of internal artery branches caused by dissection;
- Had previously received false lumen embolization;
- Proximal type I endoleak after aortic repair;
- Abdominal aortic dissection aneurysm diameter > 5 cm
- Infectious aortic disease, arteritis, Marfan syndrome (or other connective tissue diseases);
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- Acute systemic infection;
- History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- Cardiac function Grade IV (NYHA rating) or LVEF < 30%;
- Hematological abnormalities: leukopenia (WBC < 3×10^9/L), anemia (Hb < 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count < 50×10^9/L);
- Renal insufficiency: serum creatinine > 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis;
- Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times;
- Allergic to contrast agents, anesthetics, plugs, and delivery materials;
- Pregnant, breastfeeding or cannot contraception during the trial period;
- Participated in clinical trials of other drugs or devices during the same period;
- Life expectancy is less than 12 months (such as advanced malignant tumors);
- Investigator judged that not suitable for interventional treatment.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Chinese PLA Gencral Hosptial
Beijing, Beijing Municipality
Wei Guo, Pla301dml@vip.sina.com
- Recruiting
The People's Hospital of Gaozhou
Gaozhou, Guangdong
Yu Cao, professor
Yu Cao, professor
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Weiguo Fu, professor
Weiguo Fu, professor
About this study
A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.
- Conditions
- Aortic Dissection Aneurysm
- Being tested
- Aorta Vascular Plug System
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aorta Vascular Plug SystemDevice
The Aorta Vascular Plug System for false lumen is composed of a vascular plug system and an adjustable bend conveyor. The plug system is composed of a patch and a conveying steel cable. The plug is pre-installed on the conveying steel cable.
| Study group | Role | What they receive |
|---|---|---|
| WeFlow-EndoSeal Aorta Vascular Plug System | Experimental | WeFlow-EndoSeal Aorta Vascular Plug System Receives: Device: Aorta Vascular Plug System |
What is being measured
The primary outcome is the main question the study is designed to answer.
No major adverse events within 30 days after operation.
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.
Measured: 30 days after operation
All-cause mortality
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes.
Measured: 30 days, 6 months, and 12 months after operation
Aortic dissection-related mortality,
Refers to mortality caused by a ruptured aortic dissection or endovascular interventional treatment.
Measured: 30 days, 6 months, and 12 months after operation
Serious adverse events.
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Measured: 30 days, 6 months, and 12 months after operation
False lumen thrombosis of the descending thoracic aorta
False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.
Measured: 1 month, 6 months, and 12 months after operation
Aortic dissection progression under control
Aortic dissection progression under control is defined as maximum increase in the diameter of false lumen diameter in descending thoracic aorta was ≤ 5 mm when compared with preoperative aortic dissection as of postoperative CTA review.
Measured: 1 month, 6 months, and 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start24 Oct 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection AneurysmStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062524
- Sponsor's protocol ID
- Endoseal V1.0
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
- ClinicalTrials.gov ID
- NCT06062524
- Acronym / sponsor ID
- Endoseal V1.0
- Conditions
- Aortic Dissection Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 2 Oct 2023 (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.
A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WeFlow-EndoSeal Aorta Vascular Plug System | Experimental | Device: Aorta Vascular Plug SystemWeFlow-EndoSeal Aorta Vascular Plug System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 to 80 years old, no gender limitation;
- The patient was diagnosed with a dissecting aneurysm of the descending thoracic aorta after the repair of the main artery dissection, and the treatment indications were one of the following:
- The diameter of false lumen approximately 1 cm superiorly to the celiac trunk ≤40 mm
- Appropriate anatomical conditions were assessed by imaging to allow the adjustable bend conveyor to enter the pseudolumen through tears of the iliac artery, subrenal aorta, or renal artery levels.
- Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.
Key exclusion criteria (17 listed)
- Aortic rupture;
- Continuous malperfusion of internal artery branches caused by dissection;
- Had previously received false lumen embolization;
- Proximal type I endoleak after aortic repair;
- Abdominal aortic dissection aneurysm diameter > 5 cm
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 |
|---|---|---|
| Aorta Vascular Plug SystemThe Aorta Vascular Plug System for false lumen is composed of a vascular plug system and an adjustable bend conveyor. The plug system is composed of a patch and a conveying steel cable. The plug is pre-installed on the conveying steel cable. | Device | WeFlow-EndoSeal Aorta Vascular Plug System |
Primary outcome
No major adverse events within 30 days after operation.
Time frame: 30 days after operation
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.
All-cause mortality
Time frame: 30 days, 6 months, and 12 months after operation
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes.
Aortic dissection-related mortality,
Time frame: 30 days, 6 months, and 12 months after operation
Refers to mortality caused by a ruptured aortic dissection or endovascular interventional treatment.
Serious adverse events.
Time frame: 30 days, 6 months, and 12 months after operation
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
False lumen thrombosis of the descending thoracic aorta
Time frame: 1 month, 6 months, and 12 months after operation
False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.
Aortic dissection progression under control
Time frame: 1 month, 6 months, and 12 months after operation
Aortic dissection progression under control is defined as maximum increase in the diameter of false lumen diameter in descending thoracic aorta was ≤ 5 mm when compared with preoperative aortic dissection as of postoperative CTA review.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aorta Vascular Plug System in people with Aortic Dissection Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 3 sites 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 8 inclusion and 17 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Wei Guo, Professor (13910758706, Pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No major adverse events within 30 days after operation. (time frame: 30 days after operation). The study lists 6 primary outcomes in all. 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 22 May 2024.