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Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System

Primary Purpose

Aortic Dissection Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aorta Vascular Plug 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 Dissection Aneurysm

Eligibility Criteria

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

Inclusion Criteria: Patients aged 18 to 80 years old, no gender limitation; The patient was diagnosed with a dissecting aneurysm of the descending thoracic aorta after the repair of the main artery dissection, and the treatment indications were one of the following: Aortic dissection aneurysm diameter ≥ 5.5cm The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year Symptoms associated with dissection progression, such as chest and back pain The diameter of false lumen approximately 1 cm superiorly to the celiac trunk ≤40 mm Appropriate anatomical conditions were assessed by imaging to allow the adjustable bend conveyor to enter the pseudolumen through tears of the iliac artery, subrenal aorta, or renal artery levels. Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements. Exclusion Criteria: Aortic rupture; Continuous malperfusion of internal artery branches caused by dissection; Had previously received false lumen embolization; Proximal type I endoleak after aortic repair; Abdominal aortic dissection aneurysm diameter > 5 cm Infectious aortic disease, arteritis, Marfan syndrome (or other connective tissue diseases); Acute systemic infection; History of myocardial infarction, TIA or cerebral infarction within the past 3 months; Cardiac function Grade IV (NYHA rating) or LVEF < 30%; Hematological abnormalities: leukopenia (WBC < 3×10^9/L), anemia (Hb < 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count < 50×10^9/L); Renal insufficiency: serum creatinine > 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis; Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times; Allergic to contrast agents, anesthetics, plugs, and delivery materials; Pregnant, breastfeeding or cannot contraception during the trial period; Participated in clinical trials of other drugs or devices during the same period; Life expectancy is less than 12 months (such as advanced malignant tumors); Investigator judged that not suitable for interventional treatment.

Sites / Locations

  • Chinese PLA Gencral HosptialRecruiting
  • The People's Hospital of GaozhouRecruiting
  • Zhongshan Hospital Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WeFlow-EndoSeal Aorta Vascular Plug System

Arm Description

WeFlow-EndoSeal Aorta Vascular Plug System

Outcomes

Primary Outcome Measures

No major adverse events within 30 days after operation.
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.
All-cause mortality
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes.
Aortic dissection-related mortality,
Refers to mortality caused by a ruptured aortic dissection or endovascular interventional treatment.
Serious 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.
False lumen thrombosis of the descending thoracic aorta
False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.
Aortic dissection progression under control
Aortic dissection progression under control is defined as maximum increase in the diameter of false lumen diameter in descending thoracic aorta was ≤ 5 mm when compared with preoperative aortic dissection as of postoperative CTA review.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
September 28, 2023
Sponsor
Hangzhou Endonom Medtech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06062524
Brief Title
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
Official Title
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (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
A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.

6. Conditions and Keywords

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

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-EndoSeal Aorta Vascular Plug System
Arm Type
Experimental
Arm Description
WeFlow-EndoSeal Aorta Vascular Plug System
Intervention Type
Device
Intervention Name(s)
Aorta Vascular Plug System
Intervention Description
The Aorta Vascular Plug System for false lumen is composed of a vascular plug system and an adjustable bend conveyor. The plug system is composed of a patch and a conveying steel cable. The plug is pre-installed on the conveying steel cable.
Primary Outcome Measure Information:
Title
No major adverse events within 30 days after operation.
Description
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.
Time Frame
30 days after operation
Title
All-cause mortality
Description
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes.
Time Frame
30 days, 6 months, and 12 months after operation
Title
Aortic dissection-related mortality,
Description
Refers to mortality caused by a ruptured aortic dissection or endovascular interventional treatment.
Time Frame
30 days, 6 months, and 12 months after operation
Title
Serious 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
30 days, 6 months, and 12 months after operation
Title
False lumen thrombosis of the descending thoracic aorta
Description
False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.
Time Frame
1 month, 6 months, and 12 months after operation
Title
Aortic dissection progression under control
Description
Aortic dissection progression under control is defined as maximum increase in the diameter of false lumen diameter in descending thoracic aorta was ≤ 5 mm when compared with preoperative aortic dissection as of postoperative CTA review.
Time Frame
1 month, 6 months, and 12 months after operation

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, no gender limitation; The patient was diagnosed with a dissecting aneurysm of the descending thoracic aorta after the repair of the main artery dissection, and the treatment indications were one of the following: Aortic dissection aneurysm diameter ≥ 5.5cm The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year Symptoms associated with dissection progression, such as chest and back pain The diameter of false lumen approximately 1 cm superiorly to the celiac trunk ≤40 mm Appropriate anatomical conditions were assessed by imaging to allow the adjustable bend conveyor to enter the pseudolumen through tears of the iliac artery, subrenal aorta, or renal artery levels. Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements. Exclusion Criteria: Aortic rupture; Continuous malperfusion of internal artery branches caused by dissection; Had previously received false lumen embolization; Proximal type I endoleak after aortic repair; Abdominal aortic dissection aneurysm diameter > 5 cm Infectious aortic disease, arteritis, Marfan syndrome (or other connective tissue diseases); Acute systemic infection; History of myocardial infarction, TIA or cerebral infarction within the past 3 months; Cardiac function Grade IV (NYHA rating) or LVEF < 30%; Hematological abnormalities: leukopenia (WBC < 3×10^9/L), anemia (Hb < 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count < 50×10^9/L); Renal insufficiency: serum creatinine > 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis; Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times; Allergic to contrast agents, anesthetics, plugs, and delivery materials; Pregnant, breastfeeding or cannot contraception during the trial period; Participated in clinical trials of other drugs or devices during the same period; Life expectancy is less than 12 months (such as advanced malignant tumors); Investigator judged that not suitable for interventional treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Guo, Professor
Phone
13910758706
Email
Pla301dml@vip.sina.com
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
The People's Hospital of Gaozhou
City
Gaozhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Cao, professor
First Name & Middle Initial & Last Name & Degree
Yu Cao, professor
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, professor
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System

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