Time to Ambulation After ProGlide Closure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ambulation after ProGlide Closure

    Procedure/Surgery

    Ambulation 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

300 Participants
are divided into 3 treatment groups
Group A: Early Ambulation (2 hours)Experimental treatment 1 intervention
Group B: Intermediate Ambulation (6 hours)Experimental treatment 1 intervention
Group C: Late Ambulation (12 hours)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Within 24 hours post-procedure or before hospital discharge (whichever comes first)

Secondary outcomes

1

Ankle-Brachial Index (ABI) Changes

Measurement of ABI to assess potential femoral artery stenosis or occlusion at the puncture site

Time frame
Before discharge
2

Pain at Access Site (Visual Analog Scale, VAS)

Patient-reported pain score (0-10 scale) at the femoral access site.

Time frame
24 hours post-procedure
3

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.

Time frame
30 days post-procedure

Other outcomes

Sponsors and contacts

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