Femoral Access Site ClosureOPTIMANCT07179536
Time to Ambulation After ProGlide Closure
A study testing Ambulation after ProGlide Closure in people with Femoral Access Site Closure and Ambulation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Femoral Access Site Closure, Ambulation, Vascular Access Complication
- What is being tested?
- Ambulation after ProGlide Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Hui Dong, MD, 86-010-88322385, donghui666@sina.com
Xiongjing Jiang, MD, 86-010-88322387, jiangxiongjing@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoral Access Site Closure, Ambulation, Vascular Access Complication, Vascular Access Site Management
- Being tested
- Ambulation after ProGlide Closure
- Keywords
- Femoral access site closure, Vascular closure device, Time to ambulation, Vascular access complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulation after ProGlide ClosureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Ambulation (2 hours) | Experimental | Patients instructed to ambulate 2 hours after ProGlide femoral artery closure. Receives: Procedure: Ambulation after ProGlide Closure |
| Intermediate Ambulation (6 hours) | Experimental | Patients instructed to ambulate 6 hours after ProGlide femoral artery closure. Receives: Procedure: Ambulation after ProGlide Closure |
| Late Ambulation (12 hours) | Experimental | Patients instructed to ambulate 12 hours after femoral access site closure with ProGlide. Receives: Procedure: Ambulation after ProGlide Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 24 hours post-procedure or before hospital discharge (whichever comes first)
Secondary outcomes (3)
Ankle-Brachial Index (ABI) Changes
Measurement of ABI to assess potential femoral artery stenosis or occlusion at the puncture site
Measured: Before discharge
Pain at Access Site (Visual Analog Scale, VAS)
Patient-reported pain score (0-10 scale) at the femoral access site.
Measured: 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.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Oct 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Access Site ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui DONG, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Hui Dong, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179536
- Sponsor's protocol ID
- 2025-0906
- Acronym
- OPTIMA
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Time to Ambulation After ProGlide Closure of Femoral Access: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07179536
- Acronym / sponsor ID
- OPTIMA / 2025-0906
- Conditions
- Femoral Access Site Closure, Ambulation, Vascular Access Complication, Vascular Access Site Management
- Keywords
- Femoral access site closure, Vascular closure device, Time to ambulation, Vascular access complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Ambulation (2 hours) | Experimental | Procedure: Ambulation after ProGlide ClosurePatients instructed to ambulate 2 hours after ProGlide femoral artery closure. |
| Intermediate Ambulation (6 hours) | Experimental | Procedure: Ambulation after ProGlide ClosurePatients instructed to ambulate 6 hours after ProGlide femoral artery closure. |
| Late Ambulation (12 hours) | Experimental | Procedure: Ambulation after ProGlide ClosurePatients instructed to ambulate 12 hours after femoral access site closure with ProGlide. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulation after ProGlide ClosureAmbulation 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. | Procedure or surgery | Early Ambulation (2 hours), Intermediate Ambulation (6 hours), Late Ambulation (12 hours) |
Primary outcome
Incidence of Femoral Access Site Vascular Complications
Time frame: Within 24 hours post-procedure or before hospital discharge (whichever comes first)
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
3 secondary outcomes
Ankle-Brachial Index (ABI) Changes
Time frame: Before discharge
Pain at Access Site (Visual Analog Scale, VAS)
Time frame: 24 hours post-procedure
Vascular Complications within 30 Days
Time frame: 30 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui Dong, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulation after ProGlide Closure in people with Femoral Access Site Closure and Ambulation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Dong, MD (86-010-88322385, donghui666@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Femoral Access Site Vascular Complications (time frame: Within 24 hours post-procedure or before hospital discharge (whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.