N/A
N=15
Guo's Visceral Arteries Reconstruction: First in Man Study
Thoracoabdominal Aortic Aneurysm · Pararenal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT04731636 ↗Enrolled (actual)
15
Serious AEs
13.3%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thoracoabdominal aortic stent system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative |
1 | — |
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.
Eligibility Criteria
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:
- The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm > 50 mm;
- Rapid growth of sac >5 mm in diameter in the most recent 6 months;
- Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms.
- 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:
- The ilac artery landing zone 7 ~25 mm in diameter;
- The ilac artery landing zone ≥15 mm in length;
- 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
- Ruptured aortic aneurysm in unstable haemodynamic condition;
- Aneurysmal aortic dissection;
- Infected or mycotic aortic aneurysm;
- Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
- Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
- Diagnosis of acute coronary syndrome within 6 months;
- Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
- An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system;
- Patients with connective tissue diseases;
- Patients with takayasu arteritis;
- Patients with serious vital organ dysfunction or other serious disease;
- Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
- Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
- Severe coagulation dysfunction;
- Undergone major surgical or interventionic surgery within 30 days before surgery;
- Patients whose systemic or local infection may increase the risk of intravascular graft infection;
- Planning pregnancy, pregnancy, or breastfeeding;
- 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 ;
- Life expectancy less than 1 year;
- Patients not appropriate for endovascular repair based on the investigators' clinical judgement.
Data sourced from ClinicalTrials.gov (NCT04731636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.