Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07179536

Time to Ambulation After ProGlide Closure

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Hui Dong, MD

CONTACT

[email protected]

86-010-88322385

Hui Dong, MD

PRINCIPAL_INVESTIGATOR

Xiongjing Jiang, MD

CONTACT

[email protected]

86-010-88322387

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ambulation after ProGlide Closure

Procedure

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 outcomes

  1. Incidence of Femoral Access Site Vascular Complications

    Time frame: 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

Secondary outcomes

  1. Ankle-Brachial Index (ABI) Changes

    Time frame: Before discharge

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

  2. Pain at Access Site (Visual Analog Scale, VAS)

    Time frame: 24 hours post-procedure

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

  3. Vascular Complications within 30 Days

    Time frame: 30 days post-procedure

    Incidence of late access-site complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Dong, MD

CONTACT

[email protected]

86-010-88322385

Xiongjing Jiang, MD

CONTACT

[email protected]

86-010-88322387

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Acronym: OPTIMA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.