A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: Closure Strategy with Perclose-Proglide systemOther: Closure Strategy with figure-of-8
- Registration Number
- NCT05859503
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Perclose-Proglide system Closure Strategy with Perclose-Proglide system - Figure-of-8 Closure Strategy with figure-of-8 -
- Primary Outcome Measures
Name Time Method Assessment of rebleeding Discharge (assessed up to day 5) Incidence of patients with rebleeding
Rebleeding 30 days Incidence of patients with rebleeding
Assessment of Major vascular complications Discharge (assessed up to day 5) Incidence of patients with Major vascular complications
- Secondary Outcome Measures
Name Time Method Assessment of Hematoma Size 24 hours Area in cm of the hematoma at the venous puncture in patients with hematoma
Assessment of Hematoma 24 hours Incidence of patients with hematoma the venous puncture
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 Technical success 1 minute after closure performed Technical success when complete hemostasis is less than 1 minute after closure strategy performed
Assessment of Urinary infections Discharge (assessed up to day 5) Incidence of patients with urinary infection
Assessment of Clinical success Discharge (assessed up to day 5) Technical success in the absence of events after closure strategy
Assessment of Death 30 days Incidence of dead patients
Assessment of Death related to vascular access Discharge (assessed up to day 5) Incidence of dead patients related to vascular access
Assessment of Vascular access point infection 30 days Incidence of patients with infection in vascular access point
Trial Locations
- Locations (1)
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain