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)

NCT ID: NCT04765592

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2029-02-05

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.

Conditions

Aortic Arch Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WeFlow-Arch Modeler Embedded Branch Stent Graft System

Participants will be treated with WeFlow-Arch Modeler Embedded Branch Stent Graft System

Group Type: EXPERIMENTAL

WeFlow-Arch Modeler Embedded Branch Stent Graft System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Endonom Medtech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36216431 (View on PubMed)

Other Identifiers

WEIQIANG202001

Identifier Type: -

Identifier Source: org_study_id