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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYan'an Affiliated Hospital of Kunming Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≧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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hybrid TEVAR combined with long bare-metal stent intervention

    Device

    \- 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM and Fabulous® Device Surgical ImplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

30-day all-cause mortality

30-day all-cause mortality

Time frame
30 days post-intervention
2

Ratio of increase in aortic true lumen (%)

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%

Time frame
1 month, 6 months, 12 months after surgery

Secondary outcomes

1

Aortic rupture incidence

Aortic rupture incidence

Time frame
1 month, 6 months, 12 months after surgery
2

Device-related complications

* endoleak, spinal ischemia, organ failure * Classification and incidence rates

Time frame
1 month, 6 months, 12 months after surgery
3

False lumen thrombosis grading

1. Complete: No contrast enhancement 2. Partial: Partial contrast flow with thrombus 3. Patent: Full contrast opacification

Time frame
1 month, 6 months, 12 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: