Chronic Stanford B Type Aortic Dissection Proximal TearNCT04745039
Guo's Entry Tear Repair :The First in Man Study of Endopatch System
A study testing Endopatch System in people with Chronic Stanford B Type Aortic Dissection Proximal Tear, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.
Trial summary
A prospective, single-center, first in man study to evaluate the safety and efficacy of Endopatch System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the Chronic Stanford B type aortic dissection proximal tear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stanford B Type Aortic Dissection Proximal Tear
- What is being tested?
- Endopatch System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to 15 Dec 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
- Patients aged 18 to 80 years old, no gender limitation;
- Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;
- Diagnosed as chronic Stanford type B aortic dissection;
- Maximum diameter of the intimal tears is between 2mm and 20mm;
- Important branch vessels will not be covered after intimal tears closure;
- Aortic endovascular treatment can be performed with appropriate arterial access.
Who cannot join
- Diagnosed as acute, subacute aortic dissection;
- Intermural hematoma, aortic ulcer, pseudoaneurysm, and severe aortic calcification;
- The minimum distance between the intimal tears of the aortic intimal flaps and the root of the intimal flaps is less than the radius of the patch to be used (the patch cannot be deployed flat);
- Pregnant, breastfeeding or cannot contraception during the trial period;
- Participated in clinical trials of other drugs or devices during the same period;
- The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;
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- Allergic to contrast agents, anesthetics, patches, and delivery materials;
- Cannot tolerate anesthesia;
- Severe liver, kidney, lung, and heart function abnormalities before surgery [Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination];
- History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- Life expectancy is less than 12 months (such as advanced malignant tumors)
- Acute systemic infection
- Investigator judged that not suitable for interventional treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Wei Guo, 13910758706
About this study
A prospective, single-center, first in man study to evaluate the safety and efficacy of Endopatch System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the Chronic Stanford B type aortic dissection proximal tear.
- Being tested
- Endopatch System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endopatch SystemDevice
The patch system for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.
| Study group | Role | What they receive |
|---|---|---|
| Endopatch System | Experimental | Participants will be treated with Endopatch System Receives: Device: Endopatch 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 surgery.
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, liver 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
The success rate of entry tears closure 6 months after operation.
The success rate of intimal tears closure at 6 months is a composite index, including immediate technical success after the operation and no leakage of the intimal tears sealed by the DSA 6 months after the operation, no displacement of the patch, and no second occurrence during the follow-up period.
Measured: 6 months after operation
Secondary outcomes (3)
All-cause mortality, aortic dissection-related mortality, serious adverse events, and device-related adverse events.
- All-cause mortality 30 days, 6 months, and 12 months after operation;
- Mortality related to aortic dissection 30 days, 6 months, and 12 months after operation;
- Incidence of serious adverse events 30 days, 6 months, and 12 months after operation;
- Incidence of device-related adverse events 30 days, 6 months, and 12 months after operation.
Measured: 30 days, 6 months, and 12 months after operation
False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation
False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation.
Measured: 1 month, 6 months, 12 months after operation
Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation
Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation.
Measured: 1 month, 6 months, 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 posted9 Feb 2021
- Study start15 Apr 2021
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Stanford B Type Aortic Dissection Proximal TearStudies 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
- 27 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
- NCT04745039
- Sponsor's protocol ID
- Endopatch V1.0
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ge YY, Zhang HP, Guo W. A Novel Endovascular Double-Disc Implant for Sealing Intimal Tears in Aortic Dissection. JACC Asia. 2023 Nov 21;3(6):937-941. doi: 10.1016/j.jacasi.2023.09.009. eCollection 2023 Dec.
PubMed 38155784
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Entry Tear Repair :The First in Man Study of Endopatch System
- ClinicalTrials.gov ID
- NCT04745039
- Acronym / sponsor ID
- Endopatch V1.0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 9 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.
A prospective, single-center, first in man study to evaluate the safety and efficacy of Endopatch System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the Chronic Stanford B type aortic dissection proximal tear.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endopatch System | Experimental | Device: Endopatch SystemParticipants will be treated with Endopatch System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 to 80 years old, no gender limitation;
- Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;
- Diagnosed as chronic Stanford type B aortic dissection;
- Maximum diameter of the intimal tears is between 2mm and 20mm;
- Important branch vessels will not be covered after intimal tears closure;
Key exclusion criteria (13 listed)
- Diagnosed as acute, subacute aortic dissection;
- Intermural hematoma, aortic ulcer, pseudoaneurysm, and severe aortic calcification;
- The minimum distance between the intimal tears of the aortic intimal flaps and the root of the intimal flaps is less than the radius of the patch to be used (the patch cannot be deployed flat);
- Pregnant, breastfeeding or cannot contraception during the trial period;
- Participated in clinical trials of other drugs or devices during the same period;
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 |
|---|---|---|
| Endopatch SystemThe patch system for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable. | Device | Endopatch System |
Primary outcome
No major adverse events within 30 days after surgery.
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, liver 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.
The success rate of entry tears closure 6 months after operation.
Time frame: 6 months after operation
The success rate of intimal tears closure at 6 months is a composite index, including immediate technical success after the operation and no leakage of the intimal tears sealed by the DSA 6 months after the operation, no displacement of the patch, and no second occurrence during the follow-up period.
3 secondary outcomes
All-cause mortality, aortic dissection-related mortality, serious adverse events, and device-related adverse events.
Time frame: 30 days, 6 months, and 12 months after operation
False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation
Time frame: 1 month, 6 months, 12 months after operation
Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation
Time frame: 1 month, 6 months, 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Derived from this study: PubMed 38155784Ge YY, Zhang HP, Guo W. A Novel Endovascular Double-Disc Implant for Sealing Intimal Tears in Aortic Dissection. JACC Asia. 2023 Nov 21;3(6):937-941. doi: 10.1016/j.jacasi.2023.09.009. eCollection 2023 Dec.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endopatch System in people with Chronic Stanford B Type Aortic Dissection Proximal Tear, 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 6 inclusion and 13 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 19 Jul 2023. 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 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 surgery. (time frame: 30 days after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745039, which also lists 1 linked publication.
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 19 Jul 2023.