Status:
ACTIVE_NOT_RECRUITING
Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Aortic Arch Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic ...
Detailed Description
This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System, it is expected to complete the implantation of 80 patients i...
Eligibility Criteria
Inclusion
- Patients aged 18 to 80 years old;
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
- 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;
- 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;
- 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.
- Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications.
Exclusion
- Experienced systemic infection during past three months;
- Neck surgery was performed within 3 months;
- Previous endovascular interventional treatment involving the aortic arch was performed;
- Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
- Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian artery;
- Heart transplant;
- Suffered MI or stroke during past three months;
- Class IV heart function (NYHA classification);
- 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), history of bleeding or coagulopathy;
- Renal insufficiency， creatinine \> 265 umol/L (or 3.0mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by an investigator after a thorough analysis;
- Pregnant or breastfeeding;
- Allergies to contrast agents;
- Life expectancy of less than 12 months;
- Participating in another drug or device research;
- Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2029
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04765592
Start Date
June 7 2021
End Date
February 5 2029
Last Update
April 30 2024
Active Locations (23)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
2
Chinese PLA General Hospital
Beijing, China
3
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
4
Peking University People's Hospital
Beijing, China