Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.

Launched by ASSIUT UNIVERSITY · Feb 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a specific treatment, called endovascular repair, works for people with a type of aortic dissection known as Stanford type B. An aortic dissection is a serious condition where the inner layer of the aorta (the large blood vessel that carries blood from the heart) tears, which can lead to complications like rupture or reduced blood flow to vital organs. The researchers want to understand how this treatment affects the shape and stability of the aorta over time.

To participate in this trial, individuals will need to be aged 18 or older and have certain serious conditions related to their aortic dissection, such as ongoing pain or high blood pressure that doesn’t respond to treatment. They also need to have a specific type of anatomy in their aorta that allows for the placement of a stent, a small mesh tube that helps keep the aorta open. Participants can expect to undergo the endovascular repair procedure and will be monitored closely to see how their condition changes. It’s important to note that this trial is not yet recruiting participants, so it’s still in the early stages.

Gender

ALL

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.