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

July 21, 2015 updated by: Igor Bienert, Marilia Medicine School

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Marilia, SP, Brazil, 17514410
        • Marilia School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical data
Time Frame: 1 year
Registration of clinical features and procedural data, to compare with historical control group (ARISE trial - NCT01653587) using similar inclusion criteria without the objectives of the current study operator (to exclude Hawthorne effect).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marilia Medicine School

Investigators

  • Study Director: Igor RC Bienert, MD, Marilia School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 718016
  • CAAE 32767514.0.0000.5413 (Other Identifier: Plataforna Brasil)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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