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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)

NCT04765592 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2021-06-07
Last updated
2024-04-30

Condition(s) studied

Aortic Arch Aneurysm

Investigational drug(s) / intervention(s)

WeFlow-Arch Modeler Embedded Branch Stent Graft System

WeFlow-Arch Modeler Embedded Branch Stent Graft System: 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 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 arch aneurysms and ulcers involving aortic arch . (GIANT Study)

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged 18 to 80 years old; 2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch; 3. 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; 4. 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. 5. Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. Exclusion Criteria: 1. Experienced systemic infection during past three months; 2. Neck surgery was performed within 3 months; 3. Previous endovascular interventional treatment involving the aortic arch was performed; 4. Infectious aortic disease、Takayasu arteritis,Marfan syndrome (or other connective tissue diseases ); 5. Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian artery; 6. Heart transplant; 7. Suffered MI or stroke during past three months; 8. Class IV heart function (NYHA classification); 9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months; 10. 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; 11. 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; 12. Pregnant or breastfeeding; 13. Allergies to contrast agents; 14. Life expectancy of less than 12 months; 15. Participating in another drug or device research; 16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

Primary outcome measure(s)

  • Rate of all-cause mortality and major stroke within 12 months after surgery — 12 months after surgery
    All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.

Trial sites (23)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing China
Chinese PLA General Hospital Beijing China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing China
Peking University People's Hospital Beijing China
Xiangya Hospital of Central South University Changsha China
West China Hospital of Sichuan University Chengdu China
The First Affiliated Hospital ,Sun Yat-sen University Guangzhou China
First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China
Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China
The Second Affiliated Hospital of Harbin Medical University Harbin China
Shandong Provincial Hospital Jinan China
The First People's Hospital of Yunnan Province Kunming China
Nanjing Drum Tower Hospital Nanjing China
Nanjing First Hospital Nanjing China
The Affiliated Hospital Of Qingdao University Qingdao China
Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai China
The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine Shanghai China
Zhongshan Hospital, Fudan University Shanghai China
The First Affiliated Hospital of China Medical University Shenyang China
The First Affiliated Hospital Of Soochow University Suzhou China
Tianjin Medical University General Hospital Tianjin China
The First Affiliated Hospital of PLA Air Force Military Medical University Xi'an China
First Affiliated Hospital of Zhengzhou University Zhengzhou China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04765592 on ClinicalTrials.gov ↗ ← All trials in China