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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 July 2021 |
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Main ID: |
NCT02214030 |
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Date of registration:
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26/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis
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Scientific title:
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A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02214030 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ayman K.M. Hassan, MD. PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assiut University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
Patients were excluded from the study if the patient has
1. 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,
2. Arterial access other than the right or left femoral artery ,
3. Vascular perforation, thrombosis during procedure ,
4. 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
5. Uncontrolled hypertension at time of procedure (>180/>110).
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Other Vascular Adverse Event
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Common Femoral Artery Injury
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Intervention(s)
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Device: Assiut Femoral Compression Device
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Primary Outcome(s)
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the absence of major adverse events on discharge
[Time Frame: 24 post procedure]
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Time-To-Ambulation (TTA), measured in hours
[Time Frame: 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]
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Secondary Outcome(s)
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Procedure success
[Time Frame: 24 h post procedure]
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Device success:
[Time Frame: 5 minutes during application]
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Secondary ID(s)
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AUH-03
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AFCD-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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