Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization

Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization. Randomized Duplex Follow-up Study.

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

Study Overview

• Status: Unknown
• Conditions: CARDIAC CATHETRIZATION
• Intervention / Treatment: Device: ulnar artery compression device; Device: radial artery compression device; Device: radial artery compression device guided with plysthmography

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group	Device: radial artery compression device; patients undergo the conventional hemostasis compression by using a radial compression device applied at the access site.
Active Comparator: ULTRA method group	Device: ulnar artery compression device; a radial compression device will be applied at the access site. another closure device will be used for ipsilateral ulnar artery compression for 1-hour duration in order to increase peak velocity blood flow into the radi¬al artery. neither pulse oxymetry nor duplex ultrasonography will be performed in case of ulnar artery compression. after ulnar artery compression, the initial compression of the radial artery will be reduced by letting up the pressure until bleeding will be seen and then adding minimal pressure whenever needed in order to maintain radial artery patency.; Device: radial artery compression device; patients undergo the conventional hemostasis compression by using a radial compression device applied at the access site.
Active Comparator: standard patent hemostasis group	Device: radial artery compression device guided with plysthmography; a radial compression device will be applied at the access site. A pulse oximeter sensor was placed over the index finger. Transient ipsilateral ulnar artery will be occluded manually to evaluate the status of radial artery patency by plethysmography (digital pulse analysis), and if there's lack of signal, the process of deflation and reinflation of the radial artery device's bladder will be repeated over the next 15 min to attempt re-establishment of antegrade radial artery flow without affecting hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of occurrence of radial artery occlusion	the assessment will be done after compression device removal guided by duplex post trans-radial cardiac catheterization.	1 hour

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Tarek nagib, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PRCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No