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

NCT02214030 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-07-20

No results posted yet for this study

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

Conditions

  • Common Femoral Artery Injury
  • Other Vascular Adverse Event

Interventions

DEVICE

Assiut Femoral Compression Device

Assiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Ayman K.M. Hassan, MD. PhD. · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02214030 on ClinicalTrials.gov