Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Closure | Patients who received vascular closure with manual compression after percutaneous coronary intervention (PCI) | ||
| Perclose Device | Patients who received vascular closure with the Perclose VCD after percutaneous coronary intervention (PCI) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| major vascular complications | 0-30 days (during Index hospitalization) |
| Measure | Description | Time Frame |
|---|---|---|
| Minor vascular complications | 0-30 days (during index hospitalization) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who require vascular closure post percutaneous coronary intervention
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Roberts, MD | Baptist Health South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
Not provided
Not provided
Not provided
Not provided