Aortic Aneurysm and DissectionNCT05754541
Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(GRAFT Study)
A study testing WeFlow-Tribranch Aortic Arch Stent Graft System in people with Aortic Aneurysm and Dissection, run by Hangzhou Endonom Medtech Co., Ltd. at 4 sites in China.
Trial summary
To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Aneurysm and Dissection
- What is being tested?
- WeFlow-Tribranch Aortic Arch Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesChina
- Study dates
- 10 Nov 2022to 31 Dec 2025
- 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.
- The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
- Patients showing a suitable vascular condition, including:
- Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
- Proximal anchoring zone length ≥ 30 mm;
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- Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- Suitable arterial access for endovascular interventional treatment ;
- Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- Patients evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. (The recommended reference criteria are: EuroSCORE score ≥ 6, or CFS score > 4, or ASA grade 3-4, or there are other high-risk surgical factors that affect the prognosis of the subject, such as patients with a history of open surgery, other high-risk factors judged by a physician team, or patients who refuse open surgery.)
Who cannot join
- Patients that have experienced systemic infection during past three months;
- Neck surgery was performed within three months;
- Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
- Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
- Heart transplant patients;
- Patients that have suffered MI or stroke during past three months;
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- Patients with Class IV heart function (NYHA classification) or LVEF<30%
- Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
- Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acute anemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L);
- Patients with renal insufficiency， serum creatinine > 150 umol/l (or 3.0 mg/dl) and / or end-stage renal disease requiring renal dialysis shall be determined by the investigator after comprehensive analysis;
- Subjects with severe liver dysfunction and ALT or AST exceeding 3 times the upper limit of normal; Subjects whose serum total bilirubin (STB) exceeds 2 times the upper limit of normal;
- Patients with intestinal necrosis and lower limb ischemic necrosis;
- Paraplegic patients;
- Patients that are pregnant or breastfeeding;
- Patients with allergies to contrast agents;
- Patients with a life expectancy of less than 12 months;
- Patients currently participating in other drug or device research;
- Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Chinese PLA Gencral Hosptial
Beijing, Beijing Municipality
Wei Guo, Pla301dml@vip.sina.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Jia Hu, 1725194@qq.com
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210029
Xin Chen, stevecx@njmu.edu.cn
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Weiguo Fu, fu.weiguo@zs-hospital.sh.cn
About this study
Official title: Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)
To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm
Read the detailed description
The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.
- Conditions
- Aortic Aneurysm and Dissection
- Being tested
- WeFlow-Tribranch Aortic Arch Stent Graft System
- Keywords
- Stent Graft
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeFlow-Tribranch Aortic Arch Stent Graft SystemDevice
Endovascular treament in patients with aortic arch dissection and aneurysm by WeFlow-Tribranch Aortic Arch Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| WeFlow-Tribranch Aortic Arch Stent Graft System | Experimental | Not described Receives: Device: WeFlow-Tribranch Aortic Arch Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality and major stroke within 12 months after surgery.
All-cause mortality includes cardiac mortality, non-cardiac mortality and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset
Measured: 12 months post-intervention
Secondary outcomes (4)
Aortic-related mortality within 12 months post operation.
Refers to mortality caused by a ruptured aortic dissection/aneurysm or endovascular interventional treatment.
Measured: within 12 months post operation
Aortic remodeling results.
Compare the results of CTA before operation and on the 30th day, 6th month and 12th month after operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled，or CTA reexamination 12 months after operation showed that the maximum diameter of Aortic aneurysm increased by ≤ 5 mm compared with that before operation.
Measured: 1 month, 6 months and 12 months post-intervention
Major adverse events occurring within 30 days after surgery.
Refers to all-cause mortality, myocardial infarction, ischemic stroke or respiratory failure occurring within 30 days after surgery. More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes. Ischemic stroke refers to the end result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain. Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.
Measured: within 30 days after surgery
Incidence of severe 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: within 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start10 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm and DissectionStudies 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
- Investigators
- wei Guo, Principal investigator, Chinese PLA Gencral Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754541
- Sponsor's protocol ID
- WeFlow-Tribranch V1.0
- Status last verified
- Jul 2023
- First submitted
- 7 Feb 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)
- ClinicalTrials.gov ID
- NCT05754541
- Acronym / sponsor ID
- WeFlow-Tribranch V1.0
- Conditions
- Aortic Aneurysm and Dissection
- Keywords
- Stent Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 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.
To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm
Detailed description
The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WeFlow-Tribranch Aortic Arch Stent Graft System | Experimental | Device: WeFlow-Tribranch Aortic Arch Stent Graft System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged 18 to 80 years old.
- The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
- Patients showing a suitable vascular condition, including:
- Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- Patients evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. (The recommended reference criteria are: EuroSCORE score ≥ 6, or CFS score > 4, or ASA grade 3-4, or there are other high-risk surgical factors that affect the prognosis of the subject, such as patients with a history of open surgery, other high-risk factors judged by a physician team, or patients who refuse open surgery.)
Key exclusion criteria (18 listed)
- Patients that have experienced systemic infection during past three months;
- Neck surgery was performed within three months;
- Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
- Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
- Heart transplant 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 |
|---|---|---|
| WeFlow-Tribranch Aortic Arch Stent Graft SystemEndovascular treament in patients with aortic arch dissection and aneurysm by WeFlow-Tribranch Aortic Arch Stent Graft System | Device | WeFlow-Tribranch Aortic Arch Stent Graft System |
Primary outcome
All-cause mortality and major stroke within 12 months after surgery.
Time frame: 12 months post-intervention
All-cause mortality includes cardiac mortality, non-cardiac mortality and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset
4 secondary outcomes
Aortic-related mortality within 12 months post operation.
Time frame: within 12 months post operation
Aortic remodeling results.
Time frame: 1 month, 6 months and 12 months post-intervention
Major adverse events occurring within 30 days after surgery.
Time frame: within 30 days after surgery
Incidence of severe adverse events.
Time frame: within 12 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
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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.
wei Guo principal investigator
Chinese PLA Gencral Hosptial
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeFlow-Tribranch Aortic Arch Stent Graft System in people with Aortic Aneurysm and Dissection, run by Hangzhou Endonom Medtech Co., Ltd. at 4 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 11 inclusion and 18 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 (13611129129, Pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality and major stroke within 12 months after surgery. (time frame: 12 months post-intervention). 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 Aug 2023.