Status:
NOT_YET_RECRUITING
Time to Ambulation After ProGlide Closure
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Femoral Access Site Closure
Ambulation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 interventi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07179536
Start Date
October 1 2025
End Date
March 30 2026
Last Update
September 18 2025
Active Locations (1)
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1
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100037