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

Marilia Medicine School

Status: Unknown

Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Acute Coronary Syndromes

Treatments: Device: Radial; Device: TripTable; Device: Femoral

Study type: Interventional

Funder types: Other

Identifiers

NCT02200783

CAAE 32767514.0.0000.5413 (Other Identifier)

718016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

Radial

Active Comparator group

Description:

Cardiac catheterization and coronary angioplasty performed via standard radial artery technique.

Treatment:

Device: Radial

Femoral

Active Comparator group

Description:

Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique.

Treatment:

Device: Femoral

TripTable

Experimental group

Description:

Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device.

Treatment:

Device: TripTable