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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Acute Coronary Syndromes Angioplasty, Transluminal, Percutaneous Coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radial

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

Group Type ACTIVE_COMPARATOR

Radial

Intervention Type DEVICE

Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.

Femoral

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

Group Type ACTIVE_COMPARATOR

Femoral

Intervention Type DEVICE

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.

TripTable

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

Group Type EXPERIMENTAL

TripTable

Intervention Type DEVICE

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.

Interventions

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TripTable

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.

Intervention Type DEVICE

Radial

Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.

Intervention Type DEVICE

Femoral

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.

Intervention Type DEVICE

Other Intervention Names

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TRansradial Intervention Protection Table PHILIPS standard cath arm support - NCVA097

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No