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

NCT02200783 | Unknown

• 2 other identifiers: 718016CAAE 32767514.0.0000.5413
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Coronary Syndromes; Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Cardiac catheterization; Radiation Protection; Radial artery; Femoral artery

Outcome Measures

Primary Outcomes (1)

• Radiation dose

  Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)

  1 year

Secondary Outcomes (3)

• Radiation according measured site

  1 year

• Operator absorbed radiation according total radiation dose

  1 year

• Success of procedure

  1 year

Other Outcomes (1)

• Clinical data

  1 year

Study Arms (3)

Radial

ACTIVE COMPARATOR

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

Device: Radial

Femoral

ACTIVE COMPARATOR

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

Device: Femoral

TripTable

EXPERIMENTAL

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

Device: TripTable

Interventions

TripTable 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.

Also known as: TRansradial Intervention Protection Table

TripTable

Radial DEVICE

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

Also known as: PHILIPS standard cath arm support - NCVA097

Radial

Femoral 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.

Femoral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marilia Medicine School: lead

Study Sites (1)

Marilia School of Medicine

Marília, São Paulo, 17514410, Brazil

Location

Related 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.

  PMID: 21254324 BACKGROUND

• 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.

  PMID: 21586692 BACKGROUND

• Sciahbasi A, Calabro 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.

  PMID: 24746599 BACKGROUND

• 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.

  PMID: 24169135 BACKGROUND

• de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, Franca JI, 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 randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients. Trials. 2013 Dec 18;14:435. doi: 10.1186/1745-6215-14-435.

  PMID: 24345099 RESULT

• Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela 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 angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

  PMID: 21470671 RESULT

• 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 elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.

  PMID: 22858390 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Keratotomy, Radial

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Igor RC Bienert, MD

  Marilia School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

BR (1)