This trial is active, not recruiting.

Conditions acute coronary syndromes, angioplasty, transluminal, percutaneous coronary
Treatments triptable, radial, femoral
Sponsor Marilia Medicine School
Start date July 2014
End date July 2015
Trial size 99 participants
Trial identifier NCT02200783, 718016, CAAE 32767514.0.0000.5413


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Cardiac catheterization and coronary angioplasty performed via standard radial artery technique.
radial PHILIPS standard cath arm support - NCVA097
Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.
(Active Comparator)
Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique.
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.
Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device.
triptable TRansradial Intervention Protection Table
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.

Primary Outcomes

Radiation dose
time frame: 1 year

Secondary Outcomes

Radiation according measured site
time frame: 1 year
Operator absorbed radiation according total radiation dose
time frame: 1 year
Success of procedure
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Marilia Medicine School.