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

Acute Coronary Syndromes Clinical Trial

— TRIPTABLE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02200783
• Other study ID #: 718016
• Secondary ID: CAAE 32767514.0.
• Status: Active, not recruiting
• Phase: N/A
• First received: July 23, 2014
• Last updated: July 21, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Marilia Medicine School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Angioplasty, Transluminal, Percutaneous Coronary
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Marilia School of Medicine	Marilia	SP

Sponsors (1)

Lead Sponsor	Collaborator
Marilia Medicine School

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Chambers CE, Fetterly KA, Holzer R, Lin PJ, Blankenship JC, Balter S, Laskey WK. Radiation safety program for the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):546-56. doi: 10.1002/ccd.22867. Epub 2011 Jan 19. Review. — View Citation

de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, França JÍ, de Andrade MV, Barbosa RA, Labrunie A, Abizaid AA, Sousa AG. Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a — View Citation

Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj A, Niemelä M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiograph — View Citation

Park EY, Shroff AR, Crisco LV, Vidovich MI. A review of radiation exposures associated with radial cardiac catheterisation. EuroIntervention. 2013 Oct;9(6):745-53. doi: 10.4244/EIJV9I6A119. — View Citation

Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment el — View Citation

Sciahbasi A, Calabrò P, Sarandrea A, Rigattieri S, Tomassini F, Sardella G, Zavalloni D, Cortese B, Limbruno U, Tebaldi M, Gagnor A, Rubartelli P, Zingarelli A, Valgimigli M. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX). Cardiovasc Revasc Med. 2014 Jun;15(4):209-13. doi: 10.1016/j.carrev.2014.03.010. Epub 2014 Mar 26. — View Citation

Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical data	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	Yes
Primary	Radiation dose	Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)	1 year	No
Secondary	Radiation according measured site	accumulated radiation dose received by each measured site (gonadal, thyroid and lens)	1 year	No
Secondary	Operator absorbed radiation according total radiation dose	Evaluation of radiation dose to the operator according to linear correlation corrected for total dose of radiation.	1 year	No
Secondary	Success of procedure	Success rate of the procedure, as defined by perform the procedure without need to cross between techniques	1 year	No