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

Not Applicable

• Conditions: Acute Coronary Syndromes; Angioplasty, Transluminal, Percutaneous Coronary
• Interventions: Device: Radial; Device: TripTable; Device: Femoral

• Registration Number: NCT02200783
• Lead Sponsor: Marilia Medicine School

Brief 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-22
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Unstable angina with an indication for invasive stratification
• Acute coronary syndrome without ST-segment elevation
• Acute coronary syndrome with ST-segment elevation
• Patient informed of the nature of the study and have signed the Informed Consent
• Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral

Exclusion Criteria

• Below 18 years of age
• Pregnancy
• Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa,
• Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance <30 mL / min, platelet count <100,000 mm3);
• Uncontrolled hypertension;
• Cardiogenic shock;
• Previous coronary artery bypass graft surgery with the use of ≥ 1 graft
• Patients not candidates for the use of any of the specified vascular access
• Concomitant severe disease with life expectancy less than 12 months life;
• Medical, geographical, or social conditions that impede study participation
• Refusal or inability to understand and sign the informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radial	Radial	Cardiac catheterization and coronary angioplasty performed via standard radial artery technique.
TripTable	TripTable	Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device.
Femoral	Femoral	Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique.

Primary Outcome Measures

Name	Time	Method
Radiation dose	1 year	Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)

Secondary Outcome Measures

Name	Time	Method
Operator absorbed radiation according total radiation dose	1 year	Evaluation of radiation dose to the operator according to linear correlation corrected for total dose of radiation.
Radiation according measured site	1 year	accumulated radiation dose received by each measured site (gonadal, thyroid and lens)
Success of procedure	1 year	Success rate of the procedure, as defined by perform the procedure without need to cross between techniques

Trial Locations

Locations (1)

Marilia School of Medicine; 🇧🇷 Marilia, SP, Brazil