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

Vall d'Hebron University Hospital (HUVH)

Status

Enrolling

Conditions

Cardiovascular Diseases

Treatments

Other: Closure Strategy with figure-of-8

Other: Closure Strategy with Perclose-Proglide system

Study type

Observational

Funder types

Other

Identifiers

NCT05859503

PERCLOSE PROGLIDE

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.