RecruitingNot ApplicableNCT07179536

Time to Ambulation After ProGlide Closure

Optimizing Time to Ambulation After ProGlide Closure of Femoral Access: A Randomized Controlled Trial

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Enrollment

300 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ambulation Vascular Access Complication Femoral Access Site Closure Vascular Access Site Management

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria6

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.

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Interventions

PROCEDUREAmbulation 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.