WithdrawnNot Applicable

Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis

Egypt0Started 2013-09

Plain-language summary

This study was performed to evaluate the safety and efficacy of a locally designed Assiut Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety

Who can participate

Age range18 Years – 85 Years

SexALL

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Exclusion criteria

✕. Any procedural complication included:
✕. Arterial access other than the right or left femoral artery ,
✕. Vascular perforation, thrombosis during procedure ,
✕. Patients with high risk of puncture site complications as:
✕. Uncontrolled hypertension at time of procedure (\>180/\>110).

What they're measuring

Time-To-Ambulation (TTA), measured in hours

Timeframe: TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation

the absence of major adverse events on discharge

Timeframe: 24 post procedure

Trial details

NCT IDNCT02214030

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Common Femoral Artery Injury trials