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

Last updated: May 16, 2023
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

Closure Strategy with figure-of-8

Closure Strategy with Perclose-Proglide system

Clinical Study ID

NCT05859503
PERCLOSE PROGLIDE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 ≥ 14French
  • Patients with previous vascular surgery.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Closure Strategy with figure-of-8
Phase:
Study Start date:
May 16, 2023
Estimated Completion Date:
September 01, 2023

Study 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.

Connect with a study center

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

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