NCT02200783

Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes

Randomized Comparison of Radiological Exposure Between Radial and Femoral Technique Assessing Use of Protective Device Dedicated TRIPTable® in Patients With Acute Coronary Syndromes Undergoing Cardiac Catheterization

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Marilia Medicine School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access. The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.

Detailed description

This study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and radial radial technique with and without dedicated TRIPTable ® device. The TripTable device is a polycarbonate support table anatomically-designed to facilitate the radial technique, facilitating the puncturing, positioning, support to work material and providing further radioprotection from a lead layer without obstruction in viewing the fluoroscopic images.

Conditions

• Acute Coronary Syndromes
• Angioplasty, Transluminal, Percutaneous Coronary

Interventions

Type	Name	Description
DEVICE	TripTable	Details of the device previously described, designed to medical operator radioprotection. No changes in radial technique beyond the use of the supportive device will be performed.
DEVICE	Radial	Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.
DEVICE	Femoral	Standard femoral artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary. The supporting device will be the patient's own body, placing the material above the legs.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2015-12-01
• First posted: 2014-07-25
• Last updated: 2015-07-22

Locations

1 site across 1 country: Brazil