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N/A N=15 Treatment

Guo's Visceral Arteries Reconstruction: First in Man Study

Thoracoabdominal Aortic Aneurysm · Pararenal Aortic Aneurysm

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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