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

Assiut University

Status: Withdrawn

Conditions: Other Vascular Adverse Event; Common Femoral Artery Injury

Treatments: Device: Assiut Femoral Compression Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02214030

AUH-03 (Other Identifier)

AFCD-03

Details and patient eligibility

About

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

Full 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 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Assiut Femoral Compression Device

Active Comparator group

Description:

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.

Treatment:

Device: Assiut Femoral Compression Device

Manual compression

Placebo Comparator group

Description:

The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols.

Treatment:

Device: Assiut Femoral Compression Device