Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(GRAFT Study)

NCT ID: NCT05754541

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2025-12-31

Brief Summary

To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm

Detailed Description

The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.

Conditions

Aortic Aneurysm and Dissection

Study Design

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

Study Groups

WeFlow-Tribranch Aortic Arch Stent Graft System

Group Type: EXPERIMENTAL

WeFlow-Tribranch Aortic Arch Stent Graft System

Intervention Type: DEVICE

Endovascular treament in patients with aortic arch dissection and aneurysm by WeFlow-Tribranch Aortic Arch Stent Graft System

Interventions

WeFlow-Tribranch Aortic Arch Stent Graft System

Endovascular treament in patients with aortic arch dissection and aneurysm by WeFlow-Tribranch Aortic Arch Stent Graft System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 to 80 years old.

2. The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.

3. Patients showing a suitable vascular condition, including:

1. Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).

2. Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;

3. Proximal anchoring zone length ≥ 30 mm;

4. Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；

5. Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；

6. Suitable arterial access for endovascular interventional treatment ;

4. Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.

5. Patients evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. (The recommended reference criteria are: EuroSCORE score ≥ 6, or CFS score > 4, or ASA grade 3-4, or there are other high-risk surgical factors that affect the prognosis of the subject, such as patients with a history of open surgery, other high-risk factors judged by a physician team, or patients who refuse open surgery.)

Exclusion Criteria

1. Patients that have experienced systemic infection during past three months;

2. Neck surgery was performed within three months;

3. Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );

4. Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;

5. Heart transplant patients;

6. Patients that have suffered MI or stroke during past three months;

7. Patients with Class IV heart function (NYHA classification) or LVEF<30%

8. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;

9. Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acute anemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L);

10. Patients with renal insufficiency， serum creatinine > 150 umol/l (or 3.0 mg/dl) and / or end-stage renal disease requiring renal dialysis shall be determined by the investigator after comprehensive analysis;

11. Subjects with severe liver dysfunction and ALT or AST exceeding 3 times the upper limit of normal; Subjects whose serum total bilirubin (STB) exceeds 2 times the upper limit of normal;

12. Patients with intestinal necrosis and lower limb ischemic necrosis;

13. Paraplegic patients;

14. Patients that are pregnant or breastfeeding;

15. Patients with allergies to contrast agents;

16. Patients with a life expectancy of less than 12 months;

17. Patients currently participating in other drug or device research;

18. 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

Principal Investigators

wei Guo

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA Gencral Hosptial

Locations

Chinese PLA Gencral Hosptial

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Wei Guo

Role: CONTACT

Pla301dml@vip.sina.com

13611129129

Facility Contacts

Wei Guo

Role: primary

Pla301dml@vip.sina.com

Xin Chen

Role: primary

stevecx@njmu.edu.cn

Weiguo Fu

Role: primary

fu.weiguo@zs-hospital.sh.cn

Jia Hu

Role: primary

1725194@qq.com

Other Identifiers

WeFlow-Tribranch V1.0

Identifier Type: -

Identifier Source: org_study_id