Status:
WITHDRAWN
Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis
Lead Sponsor:
Assiut University
Conditions:
Common Femoral Artery Injury
Other Vascular Adverse Event
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 develo...
Detailed Description
The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. However for AFCD group, the sheaths were removed 2 hours after PCI instead of conve...
Eligibility Criteria
Inclusion
- Patients between 18 and 85 years of age,
- Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study.
- Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.
Exclusion
- Patients were excluded from the study if the patient has
- Any procedural complication included:
- prolonged chest pain,
- transient coronary artery closure, no-flow or slow-flow phenomenon,
- hemodynamic instability,
- persistent electrocardiographic changes,
- side-branch occlusion of \>1.5 mm, or
- an angiographically suboptimal result,
- Arterial access other than the right or left femoral artery ,
- Vascular perforation, thrombosis during procedure ,
- Patients with high risk of puncture site complications as:
- Bleeding diathesis,
- International normalized ratio \>1.5,
- Recent thrombolysis,
- Low platelet count,
- Hematoma at the end of the procedure,
- Previous iliofemoral artery surgery or any peripheral vascular Surgery,
- Previous femoral artery complication from angiography, and
- Uncontrolled hypertension at time of procedure (\>180/\>110).
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02214030
Start Date
September 1 2013
End Date
December 1 2018
Last Update
July 20 2021
Active Locations (1)
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1
Assiut University Hospitals
Asyut, Egypt, 71526