Impact of Femoral Access Site Closure after Percutaneous Coronary Interventions. A comparison between manual compression and the use of vascular closure device (Perclose Proglide)

All India Institute of Medical Sciences New Delhi0 个研究点目标入组 156 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 156

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1)18-85 years of age
•2)Acceptable candidate for Elective PCI through common femoral artery (CFA) using 6-8 Fr. procedural sheath
•3)Voluntary participation as per signed, informed consent by the subject

排除标准

•A)General (during Cath Selection, 6-24 hrs before PCI)
•1)Patient requiring emergency or primary PCI
•2)Anemia with pre-procedure hemoglobin < 10 gm%
•3)History of bleeding diathesis
•4)Pregnancy, suspected pregnant or lactating mothers
•5)Previous deployment of VCD in ipsilateral femoral artery at any time
•6)Peripheral vascular disease of ipsilateral limb defined as history of claudication, weak or absent pulse or lower extremity vascular graft
•7)Active systemic infection
•8)Local access site cutaneous infection or inflammation
•9)Patient known or determined to require treatment that will extend his/her hospitalization (requiring CABG, staged PCI etc.)
•10)Presence of clinically significant hematoma > 5 cm, pseudo-aneurysm or arterio-venous fistula in ipsilateral access site as detected clinically and confirmed by Doppler ultrasound.
•B)Specific (access site related, during/post PCI)
•1)Placement of arterial access sheath of < 6 or >8 Fr.
•2)Placement of both arterial and venous sheaths during PCI
•3)Difficulty inserting the introducer sheath at the start of the PCI due to vessel scarring, tortuosity, stenosis etc. as judged by the operator
•4)Intra-procedural bleeding and /or hematoma at the access site
•5)Sheath angiography reveals anatomical unsuitability for device closure, which is defined as
•i.The site of arterial puncture distal or at common femoral artery bifurcation
•ii.The site of arterial puncture above the inguinal ligament which is typically defined by the inferior border of the inferior epigastric artery or the upper third of the femoral head by plain fluoroscopy
•iii.The arterial lumen diameter at the access site is < 5mm by visual estimate
•iv.Angiographic evidence of calcified lesions at the access site

研究者

发起方

All India Institute of Medical Sciences New Delhi

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