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

NCT06892730 | Not Yet Recruiting DMC

• 2 other identifiers: YAYY-2025-00182460098
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aortic Dissection Type B

Keywords

ATBAD; TEVAR; Extension; Long bare metal scaffolding devices

Outcome Measures

Primary Outcomes (2)

• 30-day all-cause mortality

  30-day all-cause mortality

  30 days post-intervention

• 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%

  1 month, 6 months, 12 months after surgery

Secondary Outcomes (3)

• Aortic rupture incidence

  1 month, 6 months, 12 months after surgery

• Device-related complications

  1 month, 6 months, 12 months after surgery

• False lumen thrombosis grading

  1 month, 6 months, 12 months after surgery

Study Arms (1)

Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM and Fabulous® Device Surgical Implant

EXPERIMENTAL

Subjects with acute type B aortic dissection were treated with an endovascular procedure using the Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm Thoracic Aortic Endoprosthesis and the Fabulous® 45-150mm long big bare stent via femoral artery access. (Permanent implant)

Device: Hybrid TEVAR combined with long bare-metal stent intervention

Interventions

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.

Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM and Fabulous® Device Surgical Implant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≧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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Yan'an Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650051, China

Location

Related Publications (3)

• Rong D, Ge Y, Liu J, Liu X, Guo W. Combined proximal descending aortic endografting plus distal bare metal stenting (PETTICOAT technique) versus conventional proximal descending aortic stent graft repair for complicated type B aortic dissections. Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD013149. doi: 10.1002/14651858.CD013149.pub2.

  PMID: 31684692 BACKGROUND

• Fattori R, Montgomery D, Lovato L, Kische S, Di Eusanio M, Ince H, Eagle KA, Isselbacher EM, Nienaber CA. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv. 2013 Aug;6(8):876-82. doi: 10.1016/j.jcin.2013.05.003.

  PMID: 23968705 BACKGROUND

• Nienaber CA, Kische S, Zeller T, Rehders TC, Schneider H, Lorenzen B, Bunger C, Ince H. Provisional extension to induce complete attachment after stent-graft placement in type B aortic dissection: the PETTICOAT concept. J Endovasc Ther. 2006 Dec;13(6):738-46. doi: 10.1583/06-1923.1.

  PMID: 17154712 BACKGROUND

Study Officials

• Xunqiang Prof. Liu, M.D.

  Yan'an Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunqiang Prof. Liu, M.D.

CONTACT

+8613888390126; liuxunqiang1001@163.com

Zheng Dr. Jia, Ph.D.

CONTACT

+8613669776843; jiazhenghappy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label design: Participants, operators and assessors are unblinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment: All enrolled subjects receive uniform intervention protocol (TEVAR combined with long bare-metal stent intervention)

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 25, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)