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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-16

Study Completion Date

2023-09-01

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.

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Perclose-Proglide system

Closure Strategy with Perclose-Proglide system

Intervention Type OTHER

Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure

Figure-of-8

Closure Strategy with figure-of-8

Intervention Type OTHER

Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure

Interventions

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Closure Strategy with Perclose-Proglide system

Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure

Intervention Type OTHER

Closure Strategy with figure-of-8

Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure

Intervention Type OTHER

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No