Status:
UNKNOWN
Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes
Lead Sponsor:
Marilia Medicine School
Conditions:
Acute Coronary Syndromes
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT02200783
Start Date
July 1 2014
End Date
December 1 2015
Last Update
July 22 2015
Active Locations (1)
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1
Marilia School of Medicine
Marília, São Paulo, Brazil, 17514410