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

Primary Purpose

Aortic Aneurysm and Dissection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WeFlow-Tribranch Aortic Arch Stent Graft System
Sponsored by
Hangzhou Endonom Medtech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm and Dissection focused on measuring Stent Graft

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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.) Exclusion Criteria: 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; Patients with a life expectancy of less than 12 months; Patients currently participating in other drug or device research; Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

Sites / Locations

  • Chinese PLA Gencral HosptialRecruiting
  • Nanjing First HospitalRecruiting
  • Zhongshan Hospital, Fudan University
  • West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WeFlow-Tribranch Aortic Arch Stent Graft System

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Aortic-related mortality within 12 months post operation.
Refers to mortality caused by a ruptured aortic dissection/aneurysm or endovascular interventional treatment.
Aortic remodeling results.
Compare the results of CTA before operation and on the 30th day, 6th month and 12th month after operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled,or CTA reexamination 12 months after operation showed that the maximum diameter of Aortic aneurysm increased by ≤ 5 mm compared with that before operation.
Major adverse events occurring within 30 days after surgery.
Refers to all-cause mortality, myocardial infarction, ischemic stroke or respiratory failure occurring within 30 days after surgery. More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes. Ischemic stroke refers to the end result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain. Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.
Incidence of severe adverse events.
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.

Full Information

First Posted
February 7, 2023
Last Updated
August 28, 2023
Sponsor
Hangzhou Endonom Medtech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05754541
Brief Title
Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(GRAFT Study)
Official Title
Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Endonom Medtech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm and Dissection
Keywords
Stent Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WeFlow-Tribranch Aortic Arch Stent Graft System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
WeFlow-Tribranch Aortic Arch Stent Graft System
Intervention Description
Endovascular treament in patients with aortic arch dissection and aneurysm by WeFlow-Tribranch Aortic Arch Stent Graft System
Primary Outcome Measure Information:
Title
All-cause mortality and major stroke within 12 months after surgery.
Description
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
Time Frame
12 months post-intervention
Secondary Outcome Measure Information:
Title
Aortic-related mortality within 12 months post operation.
Description
Refers to mortality caused by a ruptured aortic dissection/aneurysm or endovascular interventional treatment.
Time Frame
within 12 months post operation
Title
Aortic remodeling results.
Description
Compare the results of CTA before operation and on the 30th day, 6th month and 12th month after operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled,or CTA reexamination 12 months after operation showed that the maximum diameter of Aortic aneurysm increased by ≤ 5 mm compared with that before operation.
Time Frame
1 month, 6 months and 12 months post-intervention
Title
Major adverse events occurring within 30 days after surgery.
Description
Refers to all-cause mortality, myocardial infarction, ischemic stroke or respiratory failure occurring within 30 days after surgery. More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes. Ischemic stroke refers to the end result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain. Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.
Time Frame
within 30 days after surgery
Title
Incidence of severe adverse events.
Description
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time Frame
within 12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) Exclusion Criteria: 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; Patients with a life expectancy of less than 12 months; Patients currently participating in other drug or device research; Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Guo
Phone
13611129129
Email
Pla301dml@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wei Guo
Organizational Affiliation
Chinese PLA Gencral Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA Gencral Hosptial
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo
Email
Pla301dml@vip.sina.com
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Chen
Email
stevecx@njmu.edu.cn
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiguo Fu
Email
fu.weiguo@zs-hospital.sh.cn
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Hu
Email
1725194@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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