Status:
NOT_YET_RECRUITING
Safety and Efficacy of TEVAR Combined With Long Bare-metal Stents in the Intervention of ATBAD
Lead Sponsor:
Yan'an Affiliated Hospital of Kunming Medical University
Conditions:
Aortic Dissection Type B
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of the TEVAR combined with extended bare-metal stenting (distal landing zone ≥2 cm below renal arteries) in patients with acu...
Detailed Description
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 emer...
Eligibility Criteria
Inclusion
- ≧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
- 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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06892730
Start Date
March 31 2025
End Date
March 31 2027
Last Update
March 25 2025
Active Locations (1)
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1
Yan'an Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650051