Clinical trial NCT04745624: Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With CFA Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Femoral Artery Stenosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adequate hemostasis - (efficacy)
timeFrame: within an hour immediately after procedure
measure: No complications after procedure - (safety)
timeFrame: early (48 hours)
measure: No complications after procedure - (safety)
timeFrame: late (30-day)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos Mena-Hurtado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Kim Smolderen
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.