- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04745546
Guo's Visceral Arteries Reconstruction :The First in Man Study of WeFlow-JAAA Stent Graft System
Guo's Visceral Arteries Reconstruction: The First in Man Study of WeFlow-JAAA Stent Graft System
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wei Guo, Professor
- Phone Number: +861066937166
- Email: Pla301dml@vip.sina.com
Study Contact Backup
- Name: Jiang Cao
- Phone Number: +861066937166
Study Locations
-
-
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Beijing, China
- Recruiting
- Chinese PLA General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1.18 to 80 years old; 2.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; 3.Diagnosed as a perirenal abdominal aortic aneurysm, and need to reconstruct the superior mesenteric artery and both renal arteries blood supply; 4.The diameter of the proximal anchoring area (abdominal aorta at the lower edge of the superior mesenteric artery opening) is 18-34mm; 5.The upper edge of the aneurysmal body is more than 5mm from the lower edge of the superior mesenteric artery opening; 6.The distance between the bifurcation of the renal artery and the opening of the renal artery is more than 15mm, and the diameter range of the beginning of the renal artery is 5-8mm; 7.The twist angle of the proximal tumor neck (the angle between the long axis of the normal abdominal aorta and the long axis of the tumor neck) ≥120°; 8.With proper femoral artery, iliac artery, and brachial artery approach, aortic endovascular treatment can be performed.
Exclusion Criteria:
- Severe stenosis, calcification and mural thrombosis in the proximal anchoring area;
- Pregnant, breastfeeding or cannot contraception during the trial period;
- The patient has participated in clinical trials of other drugs or devices during the same period;
- Need to intervene in other vascular diseases (such as coronary artery and carotid artery) during the same operation and the postoperative drug treatment plan is affected;
- Have history of aortic surgery or endovascular repair surgery;
- Allergic to contrast agents, anesthetics, stents 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];
- Ruptured abdominal aortic aneurysm, pseudo aortic aneurysm and dissecting aortic aneurysm;
- History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- Contraindications in the treatment of antiplatelet agents and anticoagulants;
- Life expectancy is less than 12 months (such as advanced malignant tumors)
- Acute systemic infection
- Investigator judged that not suitable for interventional treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WeFlow-JAAA Stent Graft System
Participants will be treated with WeFlow-JAAA Stent Graft System
|
The abdominal aorta stent graft system consists of the abdominal aorta embedded stent system, the abdominal aorta bifurcation stent system and the extended stent system.
The abdominal aorta embedded stent has two embedded branch stents and two fenestrations.
It can be combined with a peripheral small stent system of appropriate specifications to reconstruct the superior mesenteric artery, bilateral renal arteries and keep the abdominal trunk unobstructed.
At the same time, the combination of the abdominal aorta embedded stent, the abdominal aorta bifurcation stent and the extended stent can solve the proximal renal and transrenal abdominal aortic aneurysm lesions with the upper edge of the abdominal aortic aneurysm body and the lower edge of the superior mesenteric artery opening ≥ 5 mm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary safety endpoint
Time Frame: 30 days
|
No major adverse events related to device or surgery within 30 days after surgery : Major adverse events within 30 days after surgery are all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia, or necrosis of lower limbs. |
30 days
|
Primary effective endpoint
Time Frame: 12 months
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Treatment success rate of abdominal aortic aneurysm 12 months after operation.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary safety endpoint
Time Frame: 30 days, 6 months, 12 months
|
All-cause mortality, abdominal aortic aneurysm-related mortality, serious adverse events, device-related adverse events:
|
30 days, 6 months, 12 months
|
Secondary effective endpoint
Time Frame: 30 days, 6 months, 12 months
|
The incidence of type I or type III endoleak, the incidence of stent graft displacement, the patency rate of branch vessels, the incidence of conversion to open surgery or secondary interventional surgery.
|
30 days, 6 months, 12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WeFlow-JAAA V1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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