Aortic Arch; Aneurysm, DissectingNCT04764370
Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
A study testing WeFlow-Ach Moduler Embedded Branch Stent Graft System in people with Aortic Arch; Aneurysm, Dissecting, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.
Trial summary
This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Arch; Aneurysm, Dissecting
- What is being tested?
- WeFlow-Ach Moduler Embedded Branch Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2019to 22 Oct 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 85 years old；
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch;
- The length of the ascending aorta is greater than 4cm (from the junction of the aortic sinus tube to the proximal edge of the innominate artery)；
- Ascending aorta diameter ≥24mm and ≤44mm；
- The diameter of the iliac artery ≥7mm ；
- The diameter of the innominate artery ≤24mm, and the length ≥20mm；
- 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.
Who cannot join
- Patients with ascending aortic aneurysm, dissection, ulcer, hematoma；
- Experienced systemic infection during past three months;
- History of aortic valve repair or replacement；
- History of aortic surgery or endovascular repair surgery；
- Carotid artery is severely narrowed, calcified, clotted, twisted；
- Right axillary artery is severely narrowed, calcified, thrombosis, twisted；
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- Heart transplant；
- Suffered MI or stroke during past three months；
- Class IV heart function (NYHA classification)；
- Pregnant or breastfeeding；
- Allergies to contrast agents；
- Life expectancy less than 12 months。
Trial locations and contacts
1 site in 1 country.
About this study
This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System
Read the detailed description
The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single 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-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.
- Conditions
- Aortic Arch; Aneurysm, Dissecting
- Being tested
- WeFlow-Ach Moduler Embedded Branch Stent Graft System
- Keywords
- Aortic Arch, Aneurysm, Dissecting, Ulcers
- Medical subject headings
- Aneurysm, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeFlow-Ach Moduler Embedded Branch Stent Graft SystemDevice
The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.
| Study group | Role | What they receive |
|---|---|---|
| WeFlow-Arch Moduler Embedded Branch Stent Graft System | Experimental | Not described Receives: Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of no major adverse events related to device or surgery
Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.
Measured: 30 days after surgery
Secondary outcomes (5)
Technical success rate
Successful delivery of the stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body.
Measured: immediately after the surgery
Immediate surgery success rate
Successful delivery of the stent graft, no major adverse events related to devices or surgery.
Measured: immediately after the surgery
The clinical success rate
Clinical success rate：12 months after the operation, there was no displacement of the stent, I and III endoleak requiring treatment, aneurysm enlargement or rupture, and branch stent occlusion.
Measured: 12 months after the surgery
The incidence rate of secondary operations within 12 months after surgery
The incidence rate of secondary operations within 12 months after surgery.
Measured: 12 months after surgery
Adverse event rate within 12 months after surgery
Adverse event rate within 12 months after surgery.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start28 Feb 2019
- Primary completion22 Oct 2022
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Arch; Aneurysm, DissectingStudies 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
- 8 participants (actual)
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
- NCT04764370
- Sponsor's protocol ID
- WeFlow-Arch V1.0
- Status last verified
- Apr 2024
- First submitted
- 4 Feb 2021
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
- ClinicalTrials.gov ID
- NCT04764370
- Acronym / sponsor ID
- WeFlow-Arch V1.0
- Conditions
- Aortic Arch; Aneurysm, Dissecting
- Keywords
- Aortic Arch, Aneurysm, Dissecting, Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 21 Feb 2021 (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.
This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System
Detailed description
The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single 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-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WeFlow-Arch Moduler Embedded Branch Stent Graft System | Experimental | Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 to 85 years old；
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch;
- The length of the ascending aorta is greater than 4cm (from the junction of the aortic sinus tube to the proximal edge of the innominate artery)；
- Ascending aorta diameter ≥24mm and ≤44mm；
- The diameter of the iliac artery ≥7mm ；
Key exclusion criteria (12 listed)
- Patients with ascending aortic aneurysm, dissection, ulcer, hematoma；
- Experienced systemic infection during past three months;
- History of aortic valve repair or replacement；
- History of aortic surgery or endovascular repair surgery；
- Carotid artery is severely narrowed, calcified, clotted, twisted；
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-Ach Moduler Embedded Branch Stent Graft SystemThe modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system. | Device | WeFlow-Arch Moduler Embedded Branch Stent Graft System |
Primary outcome
Rate of no major adverse events related to device or surgery
Time frame: 30 days after surgery
Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.
5 secondary outcomes
Technical success rate
Time frame: immediately after the surgery
Immediate surgery success rate
Time frame: immediately after the surgery
The clinical success rate
Time frame: 12 months after the surgery
The incidence rate of secondary operations within 12 months after surgery
Time frame: 12 months after surgery
Adverse event rate within 12 months after surgery
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Aortic Arch; Aneurysm, Dissecting
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeFlow-Ach Moduler Embedded Branch Stent Graft System in people with Aortic Arch; Aneurysm, Dissecting, run by Hangzhou Endonom Medtech Co., Ltd. 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 30 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of no major adverse events related to device or surgery (time frame: 30 days after surgery). 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 30 Apr 2024.