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

Stanford type B aortic dissection (TBAD) accounts for 25-40% of all aortic dissections, characterized by acute onset, rapid progression, and high mortality, representing a critical cardiovascular emergency. While thoracic endovascular aortic repair (TEVAR) remains the standard intervention for TBAD, its benefits on true lumen remodeling and false lumen thrombosis are primarily limited to the stent-graft covered segment. Distal to the stent-graft, persistent re-entry tears in thoracoabdominal arteries convert preoperative exit sites into new entry points. Although TEVAR improves true lumen p...

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.

Trial Officials