Best time to walk after ProGlide femoral artery closure
Optimizing Time to Ambulation After ProGlide Closure of Femoral Access: A Randomized Controlled Trial
This trial will test different times for getting up and walking after ProGlide closure in adults having transfemoral peripheral angiography or endovascular procedures to find a timing that's safe and lets patients ambulate sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07179536 on ClinicalTrials.gov |
What this trial studies
Patients undergoing transfemoral peripheral angiography or endovascular intervention who achieve hemostasis with a 6F ProGlide device will be enrolled and assigned to predefined ambulation times after the procedure. The study will monitor vascular complications, hematoma, bleeding, limb ischemia, time to ambulation, and patient comfort. Key eligibility includes common femoral artery puncture, use of 6–8F sheaths, and preoperative ABI >0.9, while those with small femoral vessels, prior puncture-site complications, significant cardiopulmonary disease, or coagulopathy are excluded. The aim is to identify an ambulation schedule that balances patient safety with shorter bed rest and greater efficiency.
Who should consider this trial
Good fit: Adults scheduled for transfemoral peripheral angiography or endovascular intervention with a common femoral artery puncture, 6–8F sheath, successful hemostasis with a 6F ProGlide, ABI >0.9, and normal lower-limb mobility are ideal candidates.
Not a fit: Patients with femoral artery diameter <5 mm, prior vascular complications at the puncture site, abnormal cardiopulmonary function, intraoperative platelet count <80×10⁹/L or thrombolytic use, cognitive impairment, or limited lower-limb mobility are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could allow patients to get up sooner after ProGlide closure, reducing bed rest, discomfort, and length of stay without increasing vascular complications.
How similar studies have performed: Smaller reports, including work by Sekhar et al., have shown early ambulation is feasible after ProGlide closure in coronary procedures, but evidence specific to transfemoral peripheral interventions is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hui Dong, MD — Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
- Study coordinator: Hui Dong, MD
- Email: donghui666@sina.com
- Phone: 86-010-88322385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.