Cardiovascular Diseases
Conditions
Keywords
Femoral venous access closure techniques, Figure-of-8 suture,Perclose-Proglide system
Brief 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.
Interventions
OTHERClosure Strategy with Perclose-Proglide system
Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure
OTHERClosure Strategy with figure-of-8
Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Major vascular complications | 30 days | Incidence of patients with Major vascular complications |
| Assessment of rebleeding | Discharge (assessed up to day 5) | Incidence of patients with rebleeding |
| Rebleeding | 30 days | Incidence of patients with rebleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Hematoma Size | 24 hours | Area in cm of the hematoma at the venous puncture in patients with hematoma |
| Assessment of Vascular access point infection | Discharge (assessed up to day 5) | Incidence of patients with infection in vascular access point |
| Assessment of Urinary infections | 30 days | Incidence of patients with urinary infection |
| Assessment of Death | Discharge (assessed up to day 5) | Incidence of dead patients |
| Assessment of Technical success | 1 minute after closure performed | Technical success when complete hemostasis is less than 1 minute after closure strategy performed |
| Assessment of Clinical success | Discharge (assessed up to day 5) | Technical success in the absence of events after closure strategy |
| Assessment of sitting-walking time | Discharge (assessed up to day 5) | Time in hours between the patient sitting and walking after the vascular access |
| Assessment of Death related to vascular access | 30 days | Incidence of dead patients related to vascular access |
| Assessment of Hematoma | 24 hours | Incidence of patients with hematoma the venous puncture |
Countries
Spain
Contacts
Primary ContactBRUNO GARCIA DEL BLANCO, PhD, MD
Backup ContactMARIA ANGELES CARMONA
Outcome results
None listed