Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
Guo's Visceral Arteries Reconstruction, Thoracoabdominal aortic stent system, Thoracoabdominal Aortic Aneurysms, G-Branch, Pararenal abdominal aortic aneurysm
Brief summary
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.
Detailed description
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.
Interventions
Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system.
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and ≤80 years; 2. 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: 1. The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm \> 50 mm; 2. Rapid growth of sac \>5 mm in diameter in the most recent 6 months; 3. Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms. 3. Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries. 4. Proximal landing zone 20-36 mm in diameter; 5. Proximal landing zone ≥25 mm in length; 6. If distal landing zone in abdominal aorta, distal landing zone should be 12-36mm in diameter and ≥15 mm in length. 7. The visceral vascular branches landing zone 6\ 13 mm in diameter and ≥15 mm in length; 8. The renal artery landing zone 4.5\ 9 mm in diameter and ≥15 mm in length; 9. Patients who using the abdominal aortic bifurcation stent graft system should also meet the following criteria: 1. The ilac artery landing zone 7 \ 25 mm in diameter; 2. The ilac artery landing zone ≥15 mm in length; 10. Patients with appropriate iliacofemoral access and at least one patent upper extremity access; 11. 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
1. Ruptured aortic aneurysm in unstable haemodynamic condition; 2. Aneurysmal aortic dissection; 3. Infected or mycotic aortic aneurysm; 4. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries; 5. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone; 6. Diagnosis of acute coronary syndrome within 6 months; 7. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months; 8. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system； 9. Patients with connective tissue diseases; 10. Patients with takayasu arteritis; 11. Patients with serious vital organ dysfunction or other serious disease; 12. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L; 13. Severe pulmonary insufficiency who cannot tolerate general anaesthesia; 14. Severe coagulation dysfunction; 15. Undergone major surgical or interventionic surgery within 30 days before surgery; 16. Patients whose systemic or local infection may increase the risk of intravascular graft infection; 17. Planning pregnancy, pregnancy, or breastfeeding; 18. The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ; 19. Life expectancy less than 1 year; 20. Patients not appropriate for endovascular repair based on the investigators' clinical judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | G-Branch Thoracoabdominal Aortic Stent System |
|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 15 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
| Society for Vascular Surgery(SVS) score | 6 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 15 |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 2 / 15 |
Outcome results
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.
Time frame: within 30-days postoperative
Population: Total number of cases available for evaluation of adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G-Branch Thoracoabdominal Aortic Stent System | Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative | 1 participants |