Time to Ambulation After ProGlide Closure

NCT07179536 | Recruiting DMC

• 1 other identifier: 2025-0906
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Femoral access site closure; Vascular closure device; Time to ambulation; Vascular access complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ankle-Brachial Index (ABI) Changes

  Before discharge

• Pain at Access Site (Visual Analog Scale, VAS)

  24 hours post-procedure

• Vascular Complications within 30 Days

  30 days post-procedure

Study Arms (3)

Early Ambulation (2 hours)

EXPERIMENTAL

Patients instructed to ambulate 2 hours after ProGlide femoral artery closure.

Procedure: Ambulation after ProGlide Closure

Intermediate Ambulation (6 hours)

EXPERIMENTAL

Patients instructed to ambulate 6 hours after ProGlide femoral artery closure.

Procedure: Ambulation after ProGlide Closure

Late Ambulation (12 hours)

EXPERIMENTAL

Patients instructed to ambulate 12 hours after femoral access site closure with ProGlide.

Procedure: Ambulation after ProGlide Closure

Interventions

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.

Early Ambulation (2 hours); Intermediate Ambulation (6 hours); Late Ambulation (12 hours)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

Study Officials

• Hui Dong, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Dong, MD

CONTACT

86-010-88322385; donghui666@sina.com

Xiongjing Jiang, MD

CONTACT

86-010-88322387; jiangxiongjing@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (1)