Allay stent

JRCT ID: jRCTs022240031

Registered date:07/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Aortic dissection (Stanford type B)
• Date of first enrollment: 07/10/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): IVR

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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.

Exclude criteria

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

Related Information

• Primary Sponsor: Saiki Yoshikatsu
• Secondary Sponsor: Intressa