Time to Ambulation After ProGlide Closure (OPTIMA)

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

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Complication; Ambulation; Femoral Access Site Closure; Vascular Access Site Management
• Intervention / Treatment: Procedure: Ambulation after ProGlide Closure

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Dong, MD; Phone Number: 86-010-88322385; Email: donghui666@sina.com
• Study Contact Backup: Name: Xiongjing Jiang, MD; Phone Number: 86-010-88322387; Email: jiangxiongjing@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Principal Investigator: Hui Dong, MD
      • Contact: Hui Dong, MD; Phone Number: 86-010-88322385; Email: donghui666@sina.com
      • Contact: Xiongjing Jiang, MD; Phone Number: 86-010-88322387; Email: jiangxiongjing@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Ambulation (2 hours); Patients instructed to ambulate 2 hours after ProGlide femoral artery closure.	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.
Experimental: Intermediate Ambulation (6 hours); Patients instructed to ambulate 6 hours after ProGlide femoral artery closure.	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.
Experimental: Late Ambulation (12 hours); Patients instructed to ambulate 12 hours after femoral access site closure with ProGlide.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 24 hours post-procedure or before hospital discharge (whichever comes first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle-Brachial Index (ABI) Changes	Measurement of ABI to assess potential femoral artery stenosis or occlusion at the puncture site	Before discharge
Pain at Access Site (Visual Analog Scale, VAS)	Patient-reported pain score (0-10 scale) at the femoral access site.	24 hours post-procedure
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.	30 days post-procedure

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Hui Dong, MD, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: September 16, 2025
• First Posted (Actual): September 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Vascular closure device; Vascular access complication; Femoral access site closure; Time to ambulation
• Other Study ID Numbers: 2025-0906

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No