Chinese Academy of Medical Sciences, Fuwai Hospital
Phase
Not applicable
Started
2025-10-01
Last updated
2026-01-23
Condition(s) studied
Femoral Access Site ClosureAmbulationVascular Access ComplicationVascular Access Site Management
Investigational drug(s) / intervention(s)
Ambulation after ProGlide Closure
Ambulation after ProGlide Closure: 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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).
* Preoperative ankle-brachial index (ABI) \> 0.9 on both sides.
* Conscious, cooperative, and with normal lower limb mobility.
Exclusion Criteria:
* 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.
* Intraoperative platelet count \< 80 × 10⁹/L, or use of thrombolytic agents.
* Cognitive impairment, uncooperative, or limited lower limb mobility.
Primary outcome measure(s)
Incidence of Femoral Access Site Vascular Complications — Within 24 hours post-procedure or before hospital discharge (whichever comes first) 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
Trial sites (1)
Facility
City
Region
Status
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Beijing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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