Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.

Not yet recruiting

• Conditions: Type B Aortic Dissection

• Registration Number: NCT06289777
• Lead Sponsor: Assiut University

Brief Summary

Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.

Detailed Description

Aortic dissection (AD) is considered the most common catastrophic event of the aorta, and its incidence has been reported to be ≈3/100000 per year, exceeding that of ruptured abdominal aortic aneurysm.

AD is a dynamic process and can occur anywhere along the course of the aorta, with the pathognomonic lesion being an intimal tear followed by blood surging either antegrade (typically) or retrograde, cleaving the the intima and medial layers of the aortic wall longitudinally for a variable distance, thus creating a true and false lumens.

Aortic dissections are classified by chronicity, anatomic location of false lumen, generally the entry tear and longitudinal extent, and the presence or absence of complicating features.

Temporally, AD is categorized as acute phase {\<14 days}, subacute {15-90 days}, and chronic {\>90 days}.

Thoracic Endovascular Aortic Repair (TEVAR) has emerged as the first-line therapy for the treatment of AD, with better short-term results than open repair due to a significant decrease in perioperative morbidity and mortality.

By covering the primary entry tear with stent-grafts, the blood flow is redirected into the true lumen, resolving malperfusion and/or preventing rupture of the false lumen, followed by its regression and re-expansion of the true lumen, which is known as "Aortic remodeling"

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study Start: 2024-03-01
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2026-03-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Complicated Stanford type B dissections:

   • Rupture.
   • malperfusion (visceral, extremities or spinal cord ischemia).

2. High-risk aortic dissections:

   • Refractory pain, refractory hypertension or bloody pleural effusion.
   • High-risk radiographic features (max. aortic diameter >40mm, false lumen diameter >22mm, 1ry entry tear >1cm, entry tear location on the lesser curve and radiographic only malperfusin).

3. Aortic anatomy suitable for stent graft therapy:

   • Proximal landing zone (diameters between 15 and 42mm, measured form outer wall to outer wall) isn't aneurysmal, dissected or significantly thrombosed.
   • Proximal landing zone length ≥20mm.
   • Radius of curvature ≥20mm for aortic arch landing zones.
   • Arch or distal aortic angulation 45≤ degrees.

4. Compatible Iliac and/or femoral access vessel morphology (diameter and tortousity) that allows endovascular access to the dissection site with the delivery system of the appropriately sized device, with or without the use of either surigcal or endovascular conduit.

5. Age ≥18yrs.

6. Life expectancy >2yrs

Exclusion Criteria

1. Known hypersensitivity to device component or contraindication to anticoagulation or contrast media.
2. Systemic or local infection that may increase the risk of endovascular graft infection.
3. Subjects with past descending or abdominal aortic interventions.
4. Un-correctable coagulopathy
5. Active vasculitis
6. Inability or refusal to give informed consent by subject or legal representative
7. Subject is unwilling to comply with the follow-up schedule.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
technical success	baseline	successful delivery and deployment of the device with coverage of the 1ry tear at implant with no detected endoleak on angiography
Analysis of aortic remodeling	2 years	evaluation of diameter changes between the preoperative and postoperative CTs measurements in millimetres . The true lumen index (Tli) is calcuated by dividing thr true lumen diameter by the whole lumen (transaortic) diameter. The fasle lumen index (Fli) is calculated in the same manner. The desirable TLi value approaches or equals 1 (suggesting increase in true lumen to normal), whereas the sought-after FLi value approaches or equals 0 (suggesting shrinkage in false lumen).

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Asyut, Egypt