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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04801901
Other study ID # U20-04-4021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date July 29, 2022

Study information

Verified date August 2022
Source Inova Health Care Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective randomized non-blinded study to determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA).


Description:

To determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery, using ultrahigh resolution (55 MHz) ultrasound, following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA) at 90 days post-procedure. Secondary outcome measures will include metrics of procedural success at 24 hours, as well as functional assessment of pain and motor strength of the ipsilateral upper extremity at 90 days post-procedure.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date July 29, 2022
Est. primary completion date July 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Consecutive patients undergoing elective and non-emergent TR LHC and/or PCI at the INOVA Heart and Vascular Institute 2. Able to provide informed consent. 3. Patients willing to complete a 90day post PCI radial artery ultrasound. Exclusion Criteria: 1. Patients with previous cannulation of both the right and left forearm RA's for coronary angiography and/or PCI. In patients with prior cannulation of one RA, the contralateral arm may be used for this study. 2. Patients who are not willing to undergo the necessary follow-up ultrasound examinations. 3. ST elevation myocardial infarction or other emergent PCI 4. Inability to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
dTRA
Subjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA)
fTRA
Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.

Locations

Country Name City State
United States Inova Fairfax Hospital Falls Church Virginia

Sponsors (2)

Lead Sponsor Collaborator
Inova Health Care Services Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (22)

Aoi S, Htun WW, Freeo S, Lee S, Kyaw H, Alfaro V, Coppola J, Pancholy S, Kwan T. Distal transradial artery access in the anatomical snuffbox for coronary angiography as an alternative access site for faster hemostasis. Catheter Cardiovasc Interv. 2019 Nov 1;94(5):651-657. doi: 10.1002/ccd.28155. Epub 2019 Feb 24. — View Citation

Babunashvili A, Dundua D. Recanalization and reuse of early occluded radial artery within 6 days after previous transradial diagnostic procedure. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):530-6. doi: 10.1002/ccd.22846. — View Citation

Batchelor W, Dahya V, McGee D, Katopodis J, Dixon W, Campbell J, Meredith A, Knap P, Parkin M, Noel T. Ultrahigh-resolution ultrasound characterization of access site trauma and intimal hyperplasia following use of a 7F sheathless guide versus 6F sheath/guide combination for transradial artery PCI: Results of the PRAGMATIC trial. Am Heart J. 2018 Apr;198:75-83. doi: 10.1016/j.ahj.2017.11.017. Epub 2017 Dec 15. — View Citation

Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. — View Citation

Costa F, van Leeuwen MA, Daemen J, Diletti R, Kauer F, van Geuns RJ, Ligthart J, Witberg K, Zijlstra F, Valgimigli M, Van Mieghem NM. The Rotterdam Radial Access Research: Ultrasound-Based Radial Artery Evaluation for Diagnostic and Therapeutic Coronary Procedures. Circ Cardiovasc Interv. 2016 Feb;9(2):e003129. doi: 10.1161/CIRCINTERVENTIONS.115.003129. — View Citation

Ferrante G, Rao SV, Jüni P, Da Costa BR, Reimers B, Condorelli G, Anzuini A, Jolly SS, Bertrand OF, Krucoff MW, Windecker S, Valgimigli M. Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2016 Jul 25;9(14):1419-34. doi: 10.1016/j.jcin.2016.04.014. Epub 2016 Jun 29. — View Citation

Foster FS, Mehi J, Lukacs M, Hirson D, White C, Chaggares C, Needles A. A new 15-50 MHz array-based micro-ultrasound scanner for preclinical imaging. Ultrasound Med Biol. 2009 Oct;35(10):1700-8. doi: 10.1016/j.ultrasmedbio.2009.04.012. Epub 2009 Aug 3. — View Citation

Jester A, Harth A, Wind G, Germann G, Sauerbier M. Disabilities of the arm, shoulder and hand (DASH) questionnaire: Determining functional activity profiles in patients with upper extremity disorders. J Hand Surg Br. 2005 Feb;30(1):23-8. — View Citation

Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079. — View Citation

Kopin D, Seth M, Sukul D, Dixon S, Aronow HD, Lee D, Tucciarone M, Pielsticker E, Gurm HS. Primary and Secondary Vascular Access Site Complications Associated With Percutaneous Coronary Intervention: Insights From the BMC2 Registry. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2247-2256. doi: 10.1016/j.jcin.2019.05.051. Epub 2019 Aug 28. — View Citation

Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2. — View Citation

Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, Drachman DE, Valle JA, Rhodes D, Gilchrist IC; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Genomic and Precision Medicine. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement From the American Heart Association. Circ Cardiovasc Interv. 2018 Sep;11(9):e000035. doi: 10.1161/HCV.0000000000000035. — View Citation

Nairoukh Z, Jahangir S, Adjepong D, Malik BH. Distal Radial Artery Access: The Future of Cardiovascular Intervention. Cureus. 2020 Mar 7;12(3):e7201. doi: 10.7759/cureus.7201. Review. — View Citation

Pancholy S, Coppola J, Patel T, Roke-Thomas M. Prevention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Catheter Cardiovasc Interv. 2008 Sep 1;72(3):335-340. doi: 10.1002/ccd.21639. — View Citation

Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1). pii: e002686. doi: 10.1161/JAHA.115.002686. Review. — View Citation

Roghani-Dehkordi F, Hashemifard O, Sadeghi M, Mansouri R, Akbarzadeh M, Dehghani A, Akbari M. Distal accesses in the hand (two novel techniques) for percutaneous coronary angiography and intervention. ARYA Atheroscler. 2018 Mar;14(2):95-100. doi: 10.22122/arya.v14i2.1743. — View Citation

Sarkola T, Slorach C, Hui W, Bradley TJ, Redington AN, Jaeggi E. Transcutaneous very-high resolution ultrasound for the quantification of carotid arterial intima-media thickness in children - feasibility and comparison with conventional high resolution vascular ultrasound imaging. Atherosclerosis. 2012 Sep;224(1):102-7. doi: 10.1016/j.atherosclerosis.2012.06.054. Epub 2012 Jun 27. — View Citation

Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045. Review. — View Citation

Shroff A, Siddiqui S, Burg A, Singla I. Identification and management of complications of transradial procedures. Curr Cardiol Rep. 2013 Apr;15(4):350. doi: 10.1007/s11886-013-0350-x. — View Citation

Shroff AR, Gulati R, Drachman DE, Feldman DN, Gilchrist IC, Kaul P, Lata K, Pancholy SB, Panetta CJ, Seto AH, Speiser B, Steinberg DH, Vidovich MI, Woody WW, Rao SV. SCAI expert consensus statement update on best practices for transradial angiography and intervention. Catheter Cardiovasc Interv. 2020 Feb;95(2):245-252. doi: 10.1002/ccd.28672. Epub 2019 Dec 27. Review. — View Citation

Stegemann E, Sansone R, Stegemann B, Kelm M, Heiss C. Validation of High-Resolution Ultrasound Measurements of Intima-Media Thickness of the Radial Artery for the Assessment of Structural Remodeling. Angiology. 2015 Jul;66(6):574-7. doi: 10.1177/0003319714544699. Epub 2014 Aug 5. — View Citation

Valle JA, Kaltenbach LA, Bradley SM, Yeh RW, Rao SV, Gurm HS, Armstrong EJ, Messenger JC, Waldo SW. Variation in the Adoption of Transradial Access for ST-Segment Elevation Myocardial Infarction: Insights From the NCDR CathPCI Registry. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2242-2254. doi: 10.1016/j.jcin.2017.07.020. Epub 2017 Nov 1. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Radial artery intimal medial thickness following dTRA and fTRA Intimal medial thickness (mm) of the forearm radial artery followed dTRA and fTRA as assessed using ultrahigh resolution 55 MHz ultrasound probe at 90 days post cardiac catheterization. 90 days post-cardiac catheterization.
Secondary Radial artery trauma followed dTRA and fTRA Number of participants with limited access site intimal tears, dissections, thrombosis, occlusions and pseudoaneurysms of the radial artery as assessed using ultrahigh resolution 55 MHz ultrasound at the site of puncture at 90 days post cardiac catheterization 90 days post-cardiac catheterization
Secondary Functional assessment of the ipsilateral upper extremity following dTRA and fTRA Pain and motor strength of the ipsilateral upper extremity using the Borg (0-none to 10-maximal) and Disabilities of the Arm, Shoulders and Hand (DASH) (0-no disability to 100-most severe disability) scales 90 days post-cardiac catheterization. 90 days post-cardiac catheterization
Secondary Number of cannulation attempts Number of cannulation attempts prior to achieving successful vascular access 24 hours post-cardiac catheterization
Secondary Radial artery access time Time (minutes) from initial attempt to successful access of the radial artery. 24 hours post-cardiac catheterization
Secondary Access site crossover Number of patients with failure of radial artery cannulation requiring crossover to alternative radial artery access or transfemoral access 24 hours post-cardiac catheterization
Secondary Total procedural time Total procedural time (minutes) from time of access to completion of the cardiac catheterization. 24 hours post-cardiac catheterization
Secondary Duration of hemostasis Total duration of hemostasis (minutes) following completion of cardiac catheterization 24 hours post-cardiac catheterization
Secondary Incidence of hematomas Number of patients with EASY Class III or greater hematomas 24 hours post-cardiac catheterization
Secondary Percutaneous Coronary Intervention Success Achievement of Thrombolysis in Myocardial Infarction (TIMI) 3 flow following percutaneous coronary intervention 24 hours post-cardiac catheterization
Secondary Coronary dissection Iatrogenic coronary dissection at the of cardiac catheterization 24 hours post-cardiac catheterization
Secondary Myocardial infarction requiring revascularization Periprocedural myocardial infarction requiring urgent revascularization within 24 hours post-cardiac catheterization. 24 hours post-cardiac catheterization
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