An interventional study of ZIPPER aortic arch stentgraft system in Aortic Diseases, sponsored by Hangzhou Endonom Medtech Co., Ltd.. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-02.
Sponsored by Hangzhou Endonom Medtech Co., Ltd. · Not applicable, Interventional, and Treatment
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
The feasible study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 24 patients. The goal of this study is to evaluate the safety and efficacy of ZIPPER aortic arch stentgraft system in the treatment of patients with aortic arch disease, included aortic arch dissections, aneurysms, residual dissection following ascending aorta surgical operation.
108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.
This study's planned enrollment of 24 is below the median of 90 across 42 interventional studies indexed under Aortic Diseases.
Browse Aortic Diseases studies →Hangzhou Endonom Medtech Co., Ltd. is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with suitable vascular conditions, including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: ZIPPER aortic arch stentgraft system
The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
Freedom from major device/procedure-related adverse events within 30 days post-operation.
Device or procedure related major adverse events included: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, fracture, migration, access vessel thrombosis or rupture, conversion to open surgery, death.
Time frame: 30 days after intervention
Immediate postoperative technical success.
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure , and patent branch stents.
Time frame: immediately after intervention
Incidence of Type I or Type III endoleaks.
Endoleak evaluated by DSA or CTA during operation and at 1 month, 6 months and 12 months after operation. Intraoperative endoleaks that were treated with adjuvant therapy were not documented. Endoleaks occurring in the same subject after completion of the procedure, and that were not treated at different visits, are counted as once.
Time frame: 1 month, 6 months and 12 months post-intervention
Incidence of aortic arch stent graft migration.
CTA will be performed at 1, 6, and 12 months after operation to determine if the stent has migrated, and evaluations will be recorded for both the main and branch stents. Migration is defined as the main and branched stents migrate more than 10 mm at postoperative follow-up compared with that 1 month post-intervention.
Time frame: 1 month, 6 months and 12 months post-intervention
Postoperative branch vessel patency rate.
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate branch vessel revascularization and whether there is occlusion, stenosis, or stent thrombosis.
Time frame: 1 month, 6 months and 12 months post-intervention
Results of aortic remodeling after aortic dissection surgery
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of aortic remodeling, including 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.
Time frame: 1 month, 6 months and 12 months post-intervention
Progression control of aortic aneurysm
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of progression control of aortic aneurysm. The maximum diameter of aortic aneurysm increases by ≤ 5 mm after 12 months of CTA examination compared with that before surgery.
Time frame: 1 month, 6 months and 12 months post-intervention
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention.
Whether or not the patient experienced surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention will be determined.
Time frame: within 12 months post-intervention
Aortic-related mortality at 12 months post operation.
Refers to death caused by aortic rupture or endovascular treatment.
Time frame: within 12 months post-intervention
All-cause mortality and major stroke within 12 months post-procedure.
All-cause mortality includes cardiac death, non-cardiac death, and unexpected death. Major stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days after stroke onset.
Time frame: within 12 months post-intervention
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.
Time frame: within 12 months post-intervention
Incidence of device-related adverse events.
Device-related adverse event refers to an adverse medical event related to the use of test device during the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event.
Time frame: within 12 months post-intervention
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Apr 2025, 24 months after the start.
Of 21 interventional studies with no phase under Aortic Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 107. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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Hangzhou Endonom Medtech Co., Ltd.