NCT05859503

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

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Closure Strategy with Perclose-Proglide system	Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure
OTHER	Closure Strategy with figure-of-8	Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure

Timeline

• Start date: 2023-05-16
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2023-05-16
• Last updated: 2023-05-17

Locations

1 site across 1 country: Spain