A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.

Study Overview
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Brief Summary
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This study aims to compare the efficacy and safety of two strategies for closing large caliber venous access in patients undergoing percutaneous procedures: compression with figure-of-8 suture versus closure with the Perclose-Proglide system.

Detailed Description
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This is a retrospective observational study that aims to compare two strategies for closing large-caliber femoral venous access in patients who have undergone percutaneous procedures. The study's goal is to determine if there are significant differences in terms of efficacy and safety between the two closure strategies. Figure-of-8 suture compression is a well-established technique that has been used for decades to close large-bore femoral venous access, while the Perclose-Proglide system is a relatively new medical device that could have great utility for the closure of large-bore femoral venous access. By comparing these two strategies, researchers hope to determine the safety and effectiveness of the Perclose-Proglide system for closing large-bore femoral venous access in patients undergoing percutaneous procedures.

Official Title
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A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access. (PERCLOSE-PROGLIDE)

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Closure Strategy with Perclose-Proglide system
* Other: Closure Strategy with figure-of-8


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will meet all inclusion criteria: Adult patients aged > 18 years Patients who have undergone percutaneous interventional procedures Patients in whom the procedures have been performed with femoral venous access Patients who have required large caliber pods ≥ 14 French. Exclusion Criteria: Patients must not meet any exclusion criteria: Patients who have required access with surgical exposure. Patients who have required ipsilateral arterial access with a large caliber ≥ 14 French Patients with previous vascular surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perclose-Proglide system<br> | Other: Closure Strategy with Perclose-Proglide system<br>* Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure<br>|
| Figure-of-8<br> | Other: Closure Strategy with figure-of-8<br>* Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Major vascular complications | Incidence of patients with Major vascular complications | 30 days | 
| Assessment of Major vascular complications | Incidence of patients with Major vascular complications | Discharge (assessed up to day 5) | 
| Assessment of rebleeding | Incidence of patients with rebleeding | Discharge (assessed up to day 5) | 
| Rebleeding | Incidence of patients with rebleeding | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Death | Incidence of dead patients | Discharge (assessed up to day 5) | 
| Assessment of Death | Incidence of dead patients | 30 days | 
| Assessment of Death related to vascular access | Incidence of dead patients related to vascular access | 30 days | 
| Assessment of Death related to vascular access | Incidence of dead patients related to vascular access | Discharge (assessed up to day 5) | 
| Assessment of Hematoma | Incidence of patients with hematoma the venous puncture | 24 hours | 
| Assessment of Hematoma Size | Area in cm of the hematoma at the venous puncture in patients with hematoma | 24 hours | 
| Assessment of Vascular access point infection | Incidence of patients with infection in vascular access point | Discharge (assessed up to day 5) | 
| Assessment of Vascular access point infection | Incidence of patients with infection in vascular access point | 30 days | 
| Assessment of Urinary infections | Incidence of patients with urinary infection | 30 days | 
| Assessment of Urinary infections | Incidence of patients with urinary infection | Discharge (assessed up to day 5) | 
| Assessment of sitting-walking time | Time in hours between the patient sitting and walking after the vascular access | Discharge (assessed up to day 5) | 
| Assessment of Technical success | Technical success when complete hemostasis is less than 1 minute after closure strategy performed | 1 minute after closure performed | 
| Assessment of Clinical success | Technical success in the absence of events after closure strategy | Discharge (assessed up to day 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral venous access closure techniques, Figure-of-8 suture,Perclose-Proglide system