Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With CFA Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With Common Femoral Artery Disease: A Retrospective Comparison Study

Conditions
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Common Femoral Artery Stenosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5, 6 or 7 Fr access within the CFA ACT < 300 seconds Age 18 - 90 years old Severe common femoral arterial disease Percent stenosis > 50, which will be core-lab adjudicated Exclusion Criteria: Ipsilateral CFA access within 30 days preceding or subsequent to the index case Prior ipsilateral closure device use, other than VASCADE High bleeding risk ACT > 300 or > 250 with IIb/IIIa inhibitor Plt < 50K INR > 1.7 on the day of procedure Inherent coagulopathy NOAC, warfarin, or lovenox administered within 24 hours of the procedure Suspected intraluminal thrombus, dissection, pseudoaneurysm, hematoma, or AV Fistula

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| manual compression cohort<br>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<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) |