Time to Ambulation After ProGlide Closure (NCT07179536) | Clinical Trial Compass
RecruitingNot Applicable
Time to Ambulation After ProGlide Closure
China300 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Femoral Access Site Vascular Complications
Timeframe: Within 24 hours post-procedure or before hospital discharge (whichever comes first)
Trial details
NCT IDNCT07179536
SponsorChinese Academy of Medical Sciences, Fuwai Hospital