Time to Ambulation After ProGlide Closure

Official title

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

Overview

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.

Detailed description

Transradial access has replaced transfemoral access as the mainstream approach for coronary angiography and intervention due to its lower incidence of vascular complications and shorter postoperative bed rest. In non-coronary endovascular interventions, radial access is also an attractive alternative. However, the traditional femoral approach retains irreplaceable advantages: it is easier for puncture and sheath insertion, accommodates sheaths ≥ 8F, allows the delivery of larger stents, provides better guiding catheter support, and reduces procedural difficulty and time.

In recent years, the widespread use of vascular closure devices (VCDs) has further improved the physician and patient experience of femoral access. Compared with manual compression, VCDs significantly reduce hemostasis time, shorten postoperative bed rest, and improve patient comfort and satisfaction. VCDs can be classified into four categories based on the closure mechanism: collagen plug, suture-mediated, disc-based, and metal clip. Although comparative studies among different VCDs are limited, the efficacy and safety of suture-mediated VCDs have been well demonstrated. ProGlide, as a representative of suture-mediated VCDs, is favored for large sheath compatibility, reliable hemostasis, and low vascular complication rates.

Evidence from Aravind Sekhar et al. showed that patients undergoing diagnostic coronary angiography via femoral access could ambulate early after ProGlide closure, which is a key driver for reducing hospitalization time, lowering costs, and improving patient satisfaction. While previous studies have reported the benefit of VCDs in shortening time to ambulation, the determination of ambulation time was largely empirical, ranging from 2 to 12 hours depending on operator experience. Currently, there is a lack of evidence regarding the association between ambulation time and vascular complications at the access site. This study aims to investigate the impact of different ambulation times after ProGlide closure in patients undergoing transfemoral peripheral angiography or endovascular intervention on vascular access site complications, in order to determine the optimal timing for ambulation.

Interventions

• Procedure 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.

Primary outcome measures

• Incidence of Femoral Access Site Vascular Complications [Time frame: Within 24 hours post-procedure or before hospital discharge (whichever comes first)]

Secondary outcome measures (3)

• Ankle-Brachial Index (ABI) Changes [Time frame: Before discharge]
• Pain at Access Site (Visual Analog Scale, VAS) [Time frame: 24 hours post-procedure]
• Vascular Complications within 30 Days [Time frame: 30 days post-procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

China · 1 center

• Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sci — Beijing

Identifiers

NCT: NCT07179536 · 2025-0906

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗