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

NCT05754541 | Unknown

• 1 other identifier: WeFlow-Tribranch V1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Aortic Aneurysm and Dissection

Keywords

Stent Graft

Outcome Measures

Primary Outcomes (1)

• 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 post-intervention

Secondary Outcomes (4)

• Aortic-related mortality within 12 months post operation.

  within 12 months post operation

• Aortic remodeling results.

  1 month, 6 months and 12 months post-intervention

• Major adverse events occurring within 30 days after surgery.

  within 30 days after surgery

• Incidence of severe adverse events.

  within 12 months post-intervention

Study Arms (1)

WeFlow-Tribranch Aortic Arch Stent Graft System

EXPERIMENTAL

Device: WeFlow-Tribranch Aortic Arch Stent Graft System

Interventions

WeFlow-Tribranch Aortic Arch Stent Graft System DEVICE

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

WeFlow-Tribranch Aortic Arch 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.
• The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
• Patients 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 ;
• 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.
• 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.)

You may not qualify if:

• Patients that have experienced systemic infection during past three months;
• Neck surgery was performed within three months;
• Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
• Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
• Heart transplant patients;
• Patients that have suffered MI or stroke during past three months;
• Patients with Class IV heart function (NYHA classification) or LVEF\<30%
• 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);
• 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;
• 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;
• Patients with intestinal necrosis and lower limb ischemic necrosis;
• Paraplegic patients;
• Patients that are pregnant or breastfeeding;
• Patients with allergies to contrast agents;

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (4)

Chinese PLA Gencral Hosptial

Beijing, Beijing Municipality, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• wei Guo

  Chinese PLA Gencral Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Guo

CONTACT

13611129129; Pla301dml@vip.sina.com

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 7, 2023
• First Posted: March 6, 2023
• Study Start: November 10, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)