CompletedNot Applicable

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

United States200 participantsStarted 2020-08-20

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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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

What they're measuring

Adequate hemostasis - (efficacy)

Timeframe: within an hour immediately after procedure

No complications after procedure - (safety)

Timeframe: early (48 hours)

No complications after procedure - (safety)

Timeframe: late (30-day)

Trial details

NCT IDNCT04745624

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Common Femoral Artery Stenosis trials