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 | Active Not Recruiting

• 1 other identifier: WEIQIANG202001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 23

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)

Conditions

Aortic Arch Aneurysm

Outcome Measures

Primary Outcomes (1)

• Rate of all-cause mortality and major stroke within 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.

  12 months after surgery

Secondary Outcomes (10)

• Rate of immediate technical success following surgery

  immediately after the surgery

• Rate of aortic aneurysm progression under control

  12 months after operation

• Incidence of Type I or Type III endoleak

  immediately after the surgery, 1 month, 6 months, 12 months after the surgery

• Incidence of aortic arch stent graft displacement

  1 month, 6 months, 12 months after operation

• Postoperative branch vessel patency rate

  1 month, 6 months, 12 months after operation

Study Arms (1)

WeFlow-Arch Modeler Embedded Branch Stent Graft System

EXPERIMENTAL

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

Device: WeFlow-Arch Modeler Embedded Branch Stent Graft System

Interventions

WeFlow-Arch Modeler Embedded Branch Stent Graft System 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.

WeFlow-Arch Modeler Embedded Branch Stent Graft System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (23)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

The First Affiliated Hospital ,Sun Yat-sen University

Guangzhou, China

Location

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Shandong Provincial Hospital

Jinan, China

Location

The First People's Hospital of Yunnan Province

Kunming, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Nanjing First Hospital

Nanjing, China

Location

The Affiliated Hospital Of Qingdao University

Qingdao, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, China

Location

The First Affiliated Hospital Of Soochow University

Suzhou, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

The First Affiliated Hospital of PLA Air Force Military Medical University

Xi'an, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Related Publications (1)

• 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.

  PMID: 36216431 DERIVED

MeSH Terms

Conditions

Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 21, 2021
• Study Start: June 7, 2021
• Primary Completion: February 5, 2025
• Study Completion (Estimated): February 5, 2029
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: It is expected that data will be obtained after study completion for at least one year.

Locations

CN (23)