Aortic dissection (Stanford type B) Aortic dissection, Stanford B
Conditions
Interventions
Allay stent implantation
Sponsors
Saiki Yoshikatsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis: Aortic dissection (Stanford type B, false lumen open type) Age: 20-85 Phase: subacute and early chronic phase between 14 days and one year after sudden onset Diameter: 40-50mm The patient is in good general condition, has adequate prognosis, can be followed up in an outpatient setting postoperatively, and can consent at his/her discretion. Inpatient or outpatient: Patients in the subacute stage (14 days to 3 months after the onset of acute dissection) are either inpatients or outpatients, Patients in the chronic phase (3 months to 1 year) are outpatients.
Exclusion criteria
Exclusion criteria: Aortic rupture or impending rupture/ after Stanford A open repair/ Aortic occlusion or severe stenosis/ hemorrhagic diathesis or coagulopathy/ shaggy aorta/ diagnosis or suspected diagnosis of Marfan syndrome and Marfan-related diseases/ an estimated/predicted poor prognosis within 1 year/Cobalt alloy allergy/ pregnancy/ contrast media allergy/ mental illuness/ absence of own intension Patients who are participating or planning to participate in a clinical trial or interventional trial/ Patients are deemed by their physicians to be undesirable subjects for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from aorta-related death (aortic rupture, death due to new aortic dissection, death due to branch occlusion) at 12 months after Allay stent implantation Freedom from aortic event (rapid expansion/impending rupture/new dissection) at 12 months after Allay stent implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary entry and main re-entry closure at 12 months after Allay stent implantation Dilatation of true lumen/ Shrinkage of false lumen Patency of main cervical branches and main visceral branches All cause deaths and reinterventions at 12 months after Allay stent implantation | — |
Contacts
Public ContactKiichiro Kumagai
Tohoku University Hospital
Outcome results
None listed