Safety and Efficacy of TEVAR Combined with Long Bare-metal Stents in the Intervention of ATBAD

Launched by YAN'AN AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medical procedure called TEVAR (Thoracic Endovascular Aneurysm Repair) combined with long bare-metal stents to treat a specific condition known as acute complicated type B aortic dissection (ATBAD). This condition involves a tear in the aorta, which can lead to serious complications. The goal of the trial is to see if this combined approach is safe and effective in keeping blood flowing properly to important areas of the body, such as the organs in the abdomen and the legs, after the procedure.

To be eligible for this trial, participants need to be between 18 and 80 years old and must have been diagnosed with an active type B aortic dissection that requires treatment with TEVAR. They should also be in the early stages of this condition, specifically within 14 days of symptom onset. Participants can expect to receive detailed medical care and monitoring throughout the trial, with the aim of preparing them for any future necessary procedures. It’s important to note that people with certain health issues, such as severe kidney problems or ongoing infections, cannot participate. This trial is currently not recruiting participants, but it aims to improve treatment options for patients with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≧18 years old, ≦80 years old;
• • Acute phase with a course of disease ≦14 days;
• • CTA confirmed diagnosis of active dissection type B in accordance with the Stanford classification in the ESC guidelines, and requiring TEVAR surgery;
• • For patients with acute non-type A and non-type B aortic dissection involving the left subclavian artery: current technologies (such as fenestration, single branch, chimney, etc.) can be used to solve the reconstruction of the left subclavian artery;
• • The distal end of the dissection exceeds the renal artery plane;
• • Signed informed consent (emergency waiver applicable), with primary intervention using CTAG devices. Adjunctive procedures may include LSA revascularization, percutaneous fenestration, aortic/peripheral stenting, surgical fenestration, or bypass grafting.
• • Medical record completeness \>90% with mandatory CTA data;
• • Protocol compliance including follow-up adherence
• Exclusion Criteria:
• • Dissection termination above renal arteries;
• • Major aortic surgery within 30 days prior (except LSA revascularization);
• • Iliofemoral stenosis/angulation precluding endovascular access;
• • Non-diagnostic CTA image quality;
• • Indeterminate symptom onset time;
• • Traumatic TBAD, intramural hematoma, or penetrating aortic ulcer;
• • Complete thoracic aortic thrombosis pre-TEVAR;
• • Re-intervention within 12 months post-TEVAR for non-aortic indications;
• • Renal failure: Baseline serum creatinine \>2.5 mg/dL (high-risk for contrast nephropathy);
• • Known device material hypersensitivity;
• • Systemic infection increasing endograft infection risk;
• • Evidence of aortic infection;
• • Connective tissue disorders (e.g., Marfan syndrome);
• • Bowel necrosis from visceral ischemia;
• • Participation in other device/drug trials within 1 year;
• • Moribund status: ASA class 5 with \<24h life expectancy;
• • Refractory shock (SBP \<90 mmHg);
• • Pregnancy or lactation;
• • Active substance abuse.