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

Study Overview
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Brief Summary
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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

Detailed Description
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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 conventional 6 hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure till distal pulse is palpated. Each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.

Official 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

Conditions
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Common Femoral Artery Injury, Other Vascular Adverse Event

Intervention / Treatment
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* Device: Assiut Femoral Compression Device


Participation Criteria
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Eligibility 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 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Assiut Femoral Compression Device<br>the sheaths were removed 2 hours after PCI instead of conventional 6hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure over the ensuing 8 minutes. Therefore each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes. | Device: Assiut Femoral Compression Device<br>* 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.<br>* Other names: AFCD;|
| Placebo Comparator: Manual compression<br>The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. | Device: Assiut Femoral Compression Device<br>* 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.<br>* Other names: AFCD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-To-Ambulation (TTA), measured in hours | Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression | 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 | major adverse event (MAE) was defined as symptomatic bleeding associated with hemoglobin drop ≥5 g/dL requiring blood transfusion, fatal bleeding that directly results in death, a pseudoaneurysm or arteriovenous fistula, distal arterial embolism, infections requiring administration of IV antibiotics or debridement, and the need for vascular surgery. | 24 post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success: | This was defined as easy application of the device with good fixation and stability and achieving final hemostasis. Device Stability was defined as absence of tilt and/or mobility after application of the device on top of the patient groin. Assessment of the device application was performed using a questionnaire with a scale of three grades; Easy, Difficult and Requires Improvement. Assessment of stability and fixation of the device was performed on a scale defined as Very Good, Good and Bad. | 5 minutes during application | 
| Procedure success | This was defined as hemostasis achieved by the assigned method, without the occurrence of a closure-related major adverse event (MAE). | 24 h post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral compression device, manual compression, arterial hemostasis, coronary intervention, coronary artery disease