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
    Jan 1, 2023
  • participants needed
    80
  • sponsor
    Hangzhou Endonom Medtech Co., Ltd.
Updated on 1 March 2021

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 on1 March 2021

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 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

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
Infectious aortic diseaseTakayasu arteritisMarfan 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
Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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