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

Common Femoral Artery Stenosis Clinical Trial

— VASCADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745624
• Other study ID #: 2000028947
• Status: Completed
• Start date: August 20, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Common Femoral Artery Stenosis

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Bangalore S, Bhatt DL. Femoral arterial access and closure. Circulation. 2011 Aug 2;124(5):e147-56. doi: 10.1161/CIRCULATIONAHA.111.032235. — View Citation

Noori VJ, Eldrup-Jørgensen 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate hemostasis - (efficacy)	No evidence of bleeding after device use	within an hour immediately after procedure
Primary	No complications after procedure - (safety)	Early complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality	early (48 hours)
Primary	No complications after procedure - (safety)	Late complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality	late (30-day)