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

NCT06892730 · tracked via the Priya Life Science China tracker

Sponsor

Yan'an Affiliated Hospital of Kunming Medical University

Phase

Not applicable

Started

2025-03-31

Last updated

2025-03-25

Condition(s) studied

Aortic Dissection Type B

Investigational drug(s) / intervention(s)

Hybrid TEVAR combined with long bare-metal stent intervention

Hybrid TEVAR combined with long bare-metal stent intervention: \- Primary TEVAR: Primary TEVAR: Employ Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm endograft deployed with ≥2cm proximal landing zone coverage. Concurrent bare-stenting: Post-TEVAR femoral access deployment of Fabulous® (45-150mm) long bare-metal stent with: Proximal overlap ≥3cm with TEVAR graft. Distal extension 2-6cm below renal artery plane. Maximum distal limit: above iliac bifurcation. \- Intraprocedural angiography with spinal reference mapping guides precise stent positioning relative to visceral arteries and infrarenal aorta.

Study 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 acute complicated type B aortic dissection (ATBAD).

Additionally, to prevent postoperative true lumen hypoperfusion in residual thoracoabdominal aortic dissection (visceral zone, infrarenal aorta, and iliac arteries) and persistent ischemic manifestations in visceral and lower extremity arteries post-endovascular repair, extended bare-metal stents are deployed to maintain adequate distal true lumen patency. This strategy ensures perfusion to visceral branches and lower limbs while preparing for future complete endovascular aortic repair.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

30-day all-cause mortality — 30 days post-intervention
30-day all-cause mortality
Ratio of increase in aortic true lumen (%) — 1 month, 6 months, 12 months after surgery
Ratio of increase in aortic true lumen(%) including three parameters: 1. Diameter measurement (unit: mm): The total aortic diameter was obtained based on the 2020 SVS/STS reporting standards, and then the specific values of the true lumen diameter and false lumen diameter were obtained as a percentage of the straight line between the two lumens. 2. Area measurement (unit: mm2): The aortic false lumen area = the true and false lumen area - the true lumen area on the same measurement plane. 3. The change ratio (%) of true lumen diameter (mm) and area (mm2): Definition: Postoperative true lumen diameter increase ratio: (postoperative - preoperative) / preoperative\*100% True lumen diameter increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up\*100% Postoperative true lumen area increase ratio: (postoperative - preoperative) / preoperative\*100% True lumen area increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up area\*100%

Trial sites (1)

Facility	City	Region	Status
Yan'an Affiliated Hospital of Kunming Medical University	Kunming	Yunnan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06892730 on ClinicalTrials.gov ↗ ← All trials in China