Clinical trial NCT06289777: Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.
Official title: Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type B Aortic Dissection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: complicated or high-risk acute, subacute or chronic type B aortic dissection.

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"

Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of aortic remodeling
timeFrame: 2 years
measure: technical success
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
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citation: Hagedorn MN, Meisenbacher K, Skrypnik D, Bischoff MS, Bockler D. Standing the test of time: total aortic remodeling 13 years after TEVAR for acute type B aortic dissection. Indian J Thorac Cardiovasc Surg. 2024 Jan;40(1):86-90. doi: 10.1007/s12055-023-01586-5. Epub 2023 Sep 4.
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