About this trial
Transradial access has become the standard for coronary procedures due to fewer vascular complications and shorter bed rest, yet transfemoral access remains essential for complex peripheral interventions requiring larger sheaths and stronger support. Vascular closure devices (VCDs), particularly suture-mediated devices such as ProGlide, have improved femoral access by reducing hemostasis time, ambulation delay, and patient discomfort. Although early ambulation after ProGlide closure has been reported, current practice varies widely, and the relationship between ambulation timing and vascular complications remains unclear. This trial aims to evaluate the effect of different ambulation times after ProGlide closure in transfemoral peripheral angiography or intervention, with the goal of identifying the optimal time to ambulation that balances safety and efficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for peripheral angiography or endovascular intervention via transfemoral access.
Femoral artery puncture site located at the common femoral artery.
Use of 6-8F vascular sheath.
Hemostasis achieved with 6F ProGlide closure device (defined as no active bleeding, no hematoma formation, and no ischemia of the punctured limb after closure).
Disqualifiers
Undergoing carotid artery intervention.
Femoral artery diameter < 5 mm, or effective lumen < 5 mm due to plaque burden.
History of vascular complications at the puncture site.
Abnormal cardiopulmonary function.
Trial design
Parallel
Treatments tested in this trial
Ambulation after ProGlide Closure
Procedure/SurgeryAmbulation time after femoral artery access site closure using the ProGlide vascular closure device was assigned to 2 hours, 6 hours, or 12 hours post-procedure.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Femoral Access Site Vascular Complications
Composite outcome of femoral access site vascular complications, defined as the occurrence of any of the following: (1)Bleeding events classified as BARC type 2 or higher;(2)Hematoma \> 5 cm in diameter;(3)Pseudoaneurysm ;(4)Arteriovenous fistula;(5)Femoral artery stenosis or occlusion
Secondary outcomes
Ankle-Brachial Index (ABI) Changes
Measurement of ABI to assess potential femoral artery stenosis or occlusion at the puncture site
Pain at Access Site (Visual Analog Scale, VAS)
Patient-reported pain score (0-10 scale) at the femoral access site.
Vascular Complications within 30 Days
Incidence of late access-site complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention.
Sponsors and contacts
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