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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Coronary Syndromes, Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
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* Device: TripTable
* Device: Radial
* Device: Femoral


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radial<br>Cardiac catheterization and coronary angioplasty performed via standard radial artery technique. | Device: Radial<br>* Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.<br>* Other names: PHILIPS standard cath arm support - NCVA097;|
| Active Comparator: Femoral<br>Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique. | Device: Femoral<br>* 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.<br>|
| Experimental: TripTable<br>Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device. | Device: TripTable<br>* 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.<br>* Other names: TRansradial Intervention Protection Table;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose | Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD) | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac catheterization, Radiation Protection, Radial artery, Femoral artery