Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device

Clinyx

Status

Completed

Conditions

Vascular Closure

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT00842179

CL-003

Details and patient eligibility

About

The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.

Full description

It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.

Enrollment

2,517 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
Patients who received vascular closure by manual compression at Tampa General Hospital

Exclusion criteria