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)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    80
  • sponsor
    Hangzhou Endonom Medtech Co., Ltd.
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Updated on 7 October 2022
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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)

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.

Details
Condition Aortic Arch Aneurysm
Treatment WeFlow-Arch Modeler Embedded Branch Stent Graft System
Clinical Study IdentifierNCT04765592
SponsorHangzhou Endonom Medtech Co., Ltd.
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications
representative, and willing to complete follow-up visits as required under the
protocol

Exclusion Criteria

Experienced systemic infection during past three months
Neck surgery was performed within 3 months
Previous endovascular interventional treatment involving the aortic arch was performed
Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian artery
Heart transplant
Suffered MI or stroke during past three months
Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases )
Class IV heart function (NYHA classification)
Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months
Pregnant or breastfeeding
Allergies to contrast agents
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
Life expectancy of less than 12 months
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
Participating in another drug or device research
Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment
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