Clinical trial NCT04765592: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Arch Aneurysm
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 arch aneurysms and ulcers involving aortic arch . (GIANT Study)

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 in 23 centers within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.

Eligibility criteria: 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 outcomes:
measure: Rate of all-cause mortality and major stroke within 12 months after surgery
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Rate of immediate technical success following surgery
timeFrame: immediately after the surgery
measure: Rate of aortic aneurysm progression under control
timeFrame: 12 months after operation
measure: Incidence of Type I or Type III endoleak
timeFrame: immediately after the surgery, 1 month, 6 months, 12 months after the surgery
measure: Incidence of aortic arch stent graft displacement
timeFrame: 1 month, 6 months, 12 months after operation
measure: Postoperative branch vessel patency rate
timeFrame: 1 month, 6 months, 12 months after operation
measure: Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention
timeFrame: 30 days, 6 months, and 12 months after operation
measure: Rate of major adverse events
timeFrame: 30 days post operation
measure: Rate of aortic aneurysm-related mortality
timeFrame: 12 months post operation
measure: Incidence of severe adverse events
timeFrame: 30 days, 6 months, and 12 months after operation
measure: Incidence of device-related adverse events
timeFrame: 30 days, 6 months, and 12 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: The First Affiliated Hospital ,Sun Yat-sen University
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital Of Qingdao University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital Of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xian
country: China
facility: The First Affiliated Hospital of PLA Air Force Military Medical University
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
Study officials:
References:
citation: Liu F, Zhang H, Rong D, Ge Y, Jia X, Xiong J, Ma X, Wang L, Fan T, Guo W. Protocol for Guo's aortIc Arch recoNstrucTion: a prospective, multicentre and single-arm study to evaluate the safety and efficacy of the WeFlow-Arch modular inner branch stent-graft system for aortic arch lesions (GIANT study). BMJ Open. 2022 Oct 10;12(10):e063245. doi: 10.1136/bmjopen-2022-063245.