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To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for coronary and endovascular interventions. An institutional procedural database, based on electronic medical record information will be abstracted to collect this information.
The overall objective of the study will be to examine the safety and efficacy of the VASCADE closure device compared to manual compression (standard of care) to achieve hemostasis after endovascular procedures requiring access within a severely diseased CFA.
This study will be a retrospective single center review of 200 patients undergoing endovascular procedures utilizing vascular access within a severely diseased CFA between 2018 and 2020 at Yale New Haven Hospital. A random selection of patients undergoing hemostasis with manual compression (n = 100) and VASCADE vascular closure system (n = 100) will be conducted. The two groups will then be statistically compared with respect to 48-hour and 30-day safety and efficacy outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manual compression cohort | Manual compression cohort: Patients who underwent coronary or peripheral angiograms via CFA access with moderate to severe stenosis were hemostasis was achieved via manual compression | ||
| VASCADE cohort | VASCADE cohort: Patients who underwent coronary or peripheral angiograms via CFA access with moderate to severe stenosis were hemostasis was achieved via VASCADE device closure |
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| Measure | Description | Time Frame |
|---|---|---|
| Adequate hemostasis - (efficacy) | No evidence of bleeding after device use | within an hour immediately after procedure |
| No complications after procedure - (safety) | Early complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality | early (48 hours) |
| No complications after procedure - (safety) | Late complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality | late (30-day) |
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Inclusion Criteria:
Exclusion Criteria:
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This will be a retrospective review of medical records and angiograms of patients who underwent coronary and peripheral angiograms at one institution. Patients with CFA stenosis will be identified by review of their access site angiograms. The method use for hemostasis, characteristics and outcomes will be abstracted via review of medical records.
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Mena-Hurtado, MD | Yale University | Principal Investigator |
| Kim Smolderen | Yale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21810667 | Background | Bangalore S, Bhatt DL. Femoral arterial access and closure. Circulation. 2011 Aug 2;124(5):e147-56. doi: 10.1161/CIRCULATIONAHA.111.032235. No abstract available. | |
| 30146036 | Background | Noori VJ, Eldrup-Jorgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg. 2018 Sep;68(3):887-899. doi: 10.1016/j.jvs.2018.05.019. Epub 2018 Jun 29. |
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| 17383300 | Background | Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J. 2007 Apr;153(4):606-11. doi: 10.1016/j.ahj.2006.12.014. |