Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.
The study is mainly for patients with Crawford type I-V thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm, and all subjects who passed the screening and signed the informed consent will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.
Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-Branch Thoracoabdominal Aortic Stent System | Experimental | Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the Informed Consent Form |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracoabdominal aortic stent system | Device | Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative | Major Adverse events (MAE) are defined as all-cause death, liver failure, intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction, paraplegia, myocardial infarction, and respiratory failure. | within 30-days postoperative |
Not provided
Not provided
Inclusion Criteria:
Age ≥18 and ≤80 years;
Patients diagnosed with type Crawford I-V thoracoabdominal aortic aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at least one of the following conditions:
Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.
Proximal landing zone 20-36 mm in diameter;
Proximal landing zone ≥25 mm in length;
If distal landing zone in abdominal aorta, distal landing zone should be 12-36mm in diameter and ≥15 mm in length.
The visceral vascular branches landing zone 6~13 mm in diameter and ≥15 mm in length;
The renal artery landing zone 4.5~9 mm in diameter and ≥15 mm in length;
Patients who using the abdominal aortic bifurcation stent graft system should also meet the following criteria:
Patients with appropriate iliacofemoral access and at least one patent upper extremity access;
Patients who can understand the purpose of the trial, volunntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Guo, Professor | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37926150 | Derived | Zhang HP, Ge YY, Wang JB, Fan TT, Guo W. Off the Shelf Multibranched Endograft for Thoraco-Abdominal and Pararenal Abdominal Aortic Aneurysms: a Prospective, Single Centre Study of the G-Branch Endograft. Eur J Vasc Endovasc Surg. 2024 Mar;67(3):417-425. doi: 10.1016/j.ejvs.2023.11.005. Epub 2023 Nov 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | G-Branch Thoracoabdominal Aortic Stent System | Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the informed consent form. G-Branch thoracoabdominal aortic stent system: Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of patients who treated for Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm with thoracoabdominal aortic stent system,meet all inclusion criteria and not meet any exclusion criteria and signed the Informed Consent Form
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | G-Branch Thoracoabdominal Aortic Stent System | Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the Informed Consent Form. G-Branch thoracoabdominal aortic stent system: Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | presenting the age of the 15 enrolled patients as mean ± standard deviation (SD) with thoraco-abdominal or pararenal abdominal aortic aneurysm. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative | Major Adverse events (MAE) are defined as all-cause death, liver failure, intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction, paraplegia, myocardial infarction, and respiratory failure. | Total number of cases available for evaluation of adverse events. | Posted | Number | participants | within 30-days postoperative |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G-Branch Thoracoabdominal Aortic Stent System | Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the informed consent form. G-Branch thoracoabdominal aortic stent system: Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Died of acute cerebral infarction | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor type II endoleak | Injury, poisoning and procedural complications | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical manager | LifeTechScientific | 15695219339 | Xuwei@lifetechmed.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2020 | Dec 7, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex distribution of the enrolled 15 patients with thoraco-abdominal or pararenal abdominal aortic aneurysm | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of the 15 enrolled patients with thoraco-abdominal or pararenal abdominal aortic aneurysm (exclusively Chinese). | Count of Participants | Participants |
|
| Region of Enrollment | Region of the 15 enrolled patients with thoraco-abdominal or pararenal abdominal aortic aneurysm (exclusively from China). | Count of Participants | Participants |
|
| Society for Vascular Surgery(SVS) score | The SVS score ranges from 0 to 24 and comprises eight factors: Diabetes, Tobacco Use, Hypertension, Hyperlipemia, Cardiac Status, Carotid Disease, Renal Status, and Pulmonary Status. Each factor is scored individually, and the total score reflects the severity of the patient's condition, with higher values indicating a worse outcome. | Median | Full Range | units on a scale |
|
|
|
| 1 |
| 15 |
| 2 |
| 15 |
| 2 |
| 15 |
| Renal insufficiency | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |