Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization

Assiut University

Status: Unknown

Conditions: CARDIAC CATHETRIZATION

Treatments: Device: ulnar artery compression device; Device: radial artery compression device; Device: radial artery compression device guided with plysthmography

Study type: Interventional

Funder types: Other

Identifiers

NCT03182530

PRCC

Details and patient eligibility

About

Data from literature: transradial access failure sometimes occurs due to inability to cannulate the radial artery due to radial artery spasm1 causing severe difficulties in manipulation of the guide wires and catheters along the tortuous pathways of the arteries. both mechanical stimuli and circulating catecholamines through activation of α1-adrenoreceptors, causing smooth muscle cell contraction & radial artery spasm

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal radial artery and of size ≥ 2mm by duplex.
• Normal ulnar artery by duplex.

Exclusion criteria

• Pre-procedural duplex detection of radial artery anomalies as hypoplasia, tortousity, severe calcification or radial artery diameter < 2 mm.
• Severe renal failure (creatinine clearance < 30 ml/min).
• Known peripheral vascular disease.
• Emergency procedures.
• Failure to successfully cannulate the radial artery was also a criterion for exclusion.
• Patients on warfarin therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

ULTRA method group

Active Comparator group

Treatment:

Device: radial artery compression device

Device: ulnar artery compression device

standard patent hemostasis group

Active Comparator group

Treatment:

Device: radial artery compression device guided with plysthmography

control group

Experimental group

Treatment:

Device: radial artery compression device