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

Completed

• Conditions: Common Femoral Artery Stenosis

• Registration Number: NCT04745624
• Lead Sponsor: Yale University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-08-20
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 5, 6 or 7 Fr access within the CFA
2. ACT < 300 seconds
3. Age 18 - 90 years old
4. Severe common femoral arterial disease Percent stenosis > 50, which will be core-lab adjudicated

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Exclusion Criteria

1. Ipsilateral CFA access within 30 days preceding or subsequent to the index case
2. Prior ipsilateral closure device use, other than VASCADE
3. 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
4. Suspected intraluminal thrombus, dissection, pseudoaneurysm, hematoma, or AV Fistula

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
No complications after procedure - (safety)	late (30-day)	Late complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality
Adequate hemostasis - (efficacy)	within an hour immediately after procedure	No evidence of bleeding after device use

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States