Tokyo, Dec. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059790) titled 'Efficacy analysis of intraluminal shunt for preventing hyperperfusion following carotid endoarterectomy in patients with misery perfusion' on Dec. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - cervical carotid artery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate if intraluminal shunt could prevent hyperperfusion following carotid endarterectomy in patients with misery perfusion.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Apllication of intraluminal shunt during carotid endoarterectomy for patients with internal carotid artery stenosis
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients who plan to undergo carotid endoarterectomy (CEA) and meet following criteria.
A)Patients who have misery perfusion on preoperative examinations and give consent.
B) Control group patients who had misery perfusion and underwent CEA without using intraluminal shunt between 2020/7/1 to 2025/6/30.
Key exclusion criteria - A)
1. Patients who have thinner diameter of outer diameter of intraluminal shunt tube (3mm)
2. Patients who lack required data.
B)
1. Patients who reject to be included the study
2. Patients that intraluminal shunt could not be implanted
3. Patients who lack required data.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 06 Day
Date of IRB - 2025 Year 12 Month 12 Day
Anticipated trial start date - 2025 Year 12 Month 15 Day
Last follow-up date - 2029 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068364
Disclaimer: Curated by HT Syndication.