Postcath Radial Arterial Clamp Time In the CAth Lab (PRACTICAL)

Lawson Health Research Institute

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: Vascular compression device- RADAR TM-Short clamp time; Device: Vascular compression device RADAR TM-Long clamp time

Study type: Interventional

Funder types: Other

Identifiers

NCT02269722

10796 (Other Identifier)

Details and patient eligibility

About

The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.

Full description

The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.

Enrollment: 564 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
• Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
• Patients must be able to give informed consent

Exclusion criteria

• Evidence of pre-procedural radial artery thrombosis
• Inability to give informed consent
• Patient desire not to participate in the study
• Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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564 participants in 2 patient groups

Short Clamp time

Experimental group

Description:

Radial clamp applied at full pressure for 20 minutes. At the end of 20 minutes, the clamp will be loosened ¼ turn every 5 minutes over 20 minutes and then removed.

Treatment:

Device: Vascular compression device- RADAR TM-Short clamp time

Long Clamp Time

Experimental group

Description:

Radial clamp applied at full pressure for 60 minutes. At the end of 60 minutes, the clamp is to be loosened and removed under the same instruction as those patients in arm one.

Treatment:

Device: Vascular compression device RADAR TM-Long clamp time