Transradial AccessNCT04801901
Distal Transradial Access for Percutaneous Coronary Intervention
A study testing dTRA and fTRA in people with Transradial Access and Coronary Angiography, run by Inova Health Care Services at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transradial Access, Coronary Angiography, Radial Artery Intimal Medial Thickness
- What is being tested?
- dTRA and fTRA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive patients undergoing elective and non-emergent TR LHC and/or PCI at the INOVA Heart and Vascular Institute
- Able to provide informed consent.
- Patients willing to complete a 90day post PCI radial artery ultrasound.
Who cannot join
- 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.
- Patients who are not willing to undergo the necessary follow-up ultrasound examinations.
- ST elevation myocardial infarction or other emergent PCI
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: PRESERVE Radial: A PRospEctive Randomized Clinical Study Comparing Radial ArtERy Intimal Hyperplasia Following Distal Vs. ForEarm TransRadial Arterial Access for Coronary Angiography
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).
Read the detailed 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.
- Conditions
- Transradial Access, Coronary Angiography, Radial Artery Intimal Medial Thickness, Distal Radial Artery Access (dTRA)
- Being tested
- dTRA, fTRA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dTRAProcedure or surgery
Subjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA)
fTRAProcedure or surgery
Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.
| Study group | Role | What they receive |
|---|---|---|
| Distal transradial access (dTRA) | Experimental | Subjects randomized to the experimental arm will undergo left heart catheterization using distal transradial access (dTRA) to facilitate coronary angiography and/or percutaneous coronary intervention. Receives: Procedure: dTRA |
| Forearm radial access (fTRA) | Active comparator | Cardiac catheterization to facilitate coronary angiography and/or percutaneous coronary intervention using the standard forearm radial artery which is the current standard of care in interventional cardiology. Receives: Procedure: fTRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days post-cardiac catheterization.
Secondary outcomes (11)
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
Measured: 90 days post-cardiac catheterization
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.
Measured: 90 days post-cardiac catheterization
Number of cannulation attempts
Number of cannulation attempts prior to achieving successful vascular access
Measured: 24 hours post-cardiac catheterization
Radial artery access time
Time (minutes) from initial attempt to successful access of the radial artery.
Measured: 24 hours post-cardiac catheterization
Access site crossover
Number of patients with failure of radial artery cannulation requiring crossover to alternative radial artery access or transfemoral access
Measured: 24 hours post-cardiac catheterization
Total procedural time
Total procedural time (minutes) from time of access to completion of the cardiac catheterization.
Measured: 24 hours post-cardiac catheterization
Duration of hemostasis
Total duration of hemostasis (minutes) following completion of cardiac catheterization
Measured: 24 hours post-cardiac catheterization
Incidence of hematomas
Number of patients with EASY Class III or greater hematomas
Measured: 24 hours post-cardiac catheterization
Percutaneous Coronary Intervention Success
Achievement of Thrombolysis in Myocardial Infarction (TIMI) 3 flow following percutaneous coronary intervention
Measured: 24 hours post-cardiac catheterization
Coronary dissection
Iatrogenic coronary dissection at the of cardiac catheterization
Measured: 24 hours post-cardiac catheterization
Myocardial infarction requiring revascularization
Periprocedural myocardial infarction requiring urgent revascularization within 24 hours post-cardiac catheterization.
Measured: 24 hours post-cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Oct 2021
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Transradial AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized non-blinded study evaluating whether distal radial artery access (dTRA) from the anatomic snuffbox is associated with less trauma and adverse remodeling to the forearm radial artery compared to standardard forearm radial access (fTRA).
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Dr. Wayne B. Batchelor M.D., Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801901
- Sponsor's protocol ID
- U20-04-4021
- Status last verified
- Aug 2022
- First submitted
- 7 Jan 2021
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data including demographics, cardiac history indications for cardiac catheterization and all follow up data related to primary outcome, secondary ultrasound endpoints, interventional endpoints and secondary functional outcomes will be shared.
Publications
Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103.
PubMed 2912567Ferrante G, Rao SV, Juni 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.
PubMed 27372195Kopin 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.
PubMed 31473240Valle 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.
PubMed 29102582Mason 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.
PubMed 30354598Rashid 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):e002686. doi: 10.1161/JAHA.115.002686.
PubMed 26811162Kiemeneij 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.
PubMed 28506941Babunashvili 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.
PubMed 20939038Aoi 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.
PubMed 30801939Koutouzis 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.
PubMed 30314833Nairoukh 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.
PubMed 32269880Shroff 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.
PubMed 31880380Roghani-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.
PubMed 30108641Sgueglia 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.
PubMed 30336816Batchelor 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.
PubMed 29653651
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESERVE Radial: A PRospEctive Randomized Clinical Study Comparing Radial ArtERy Intimal Hyperplasia Following Distal Vs. ForEarm TransRadial Arterial Access for Coronary Angiography
- ClinicalTrials.gov ID
- NCT04801901
- Acronym / sponsor ID
- U20-04-4021
- Conditions
- Transradial Access, Coronary Angiography, Radial Artery Intimal Medial Thickness, Distal Radial Artery Access (dTRA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized non-blinded study evaluating whether distal radial artery access (dTRA) from the anatomic snuffbox is associated with less trauma and adverse remodeling to the forearm radial artery compared to standardard forearm radial access (fTRA).
| Arm | Type | Receives |
|---|---|---|
| Distal transradial access (dTRA) | Experimental | Procedure: dTRASubjects randomized to the experimental arm will undergo left heart catheterization using distal transradial access (dTRA) to facilitate coronary angiography and/or percutaneous coronary intervention. |
| Forearm radial access (fTRA) | Active comparator | Procedure: fTRACardiac catheterization to facilitate coronary angiography and/or percutaneous coronary intervention using the standard forearm radial artery which is the current standard of care in interventional cardiology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients undergoing elective and non-emergent TR LHC and/or PCI at the INOVA Heart and Vascular Institute
- Able to provide informed consent.
- Patients willing to complete a 90day post PCI radial artery ultrasound.
Key exclusion criteria (4 listed)
- 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.
- Patients who are not willing to undergo the necessary follow-up ultrasound examinations.
- ST elevation myocardial infarction or other emergent PCI
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dTRASubjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA) | Procedure or surgery | Distal transradial access (dTRA) |
| fTRALeft heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery. | Procedure or surgery | Forearm radial access (fTRA) |
Primary outcome
Radial artery intimal medial thickness following dTRA and fTRA
Time frame: 90 days post-cardiac catheterization.
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.
11 secondary outcomes
Radial artery trauma followed dTRA and fTRA
Time frame: 90 days post-cardiac catheterization
Functional assessment of the ipsilateral upper extremity following dTRA and fTRA
Time frame: 90 days post-cardiac catheterization
Number of cannulation attempts
Time frame: 24 hours post-cardiac catheterization
Radial artery access time
Time frame: 24 hours post-cardiac catheterization
Access site crossover
Time frame: 24 hours post-cardiac catheterization
Total procedural time
Time frame: 24 hours post-cardiac catheterization
Duration of hemostasis
Time frame: 24 hours post-cardiac catheterization
Incidence of hematomas
Time frame: 24 hours post-cardiac catheterization
Percutaneous Coronary Intervention Success
Time frame: 24 hours post-cardiac catheterization
Coronary dissection
Time frame: 24 hours post-cardiac catheterization
Myocardial infarction requiring revascularization
Time frame: 24 hours post-cardiac catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 2912567Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103.
- Background: PubMed 27372195Ferrante G, Rao SV, Juni 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.
- Background: PubMed 31473240Kopin 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.
- Background: PubMed 29102582Valle 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.
- Background: PubMed 30354598Mason 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.
- Background: PubMed 26811162Rashid 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):e002686. doi: 10.1161/JAHA.115.002686.
- Background: PubMed 28506941Kiemeneij 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.
- Background: PubMed 20939038Babunashvili 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.
- Background: PubMed 30801939Aoi 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.
- Background: PubMed 30314833Koutouzis 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.
- Background: PubMed 32269880Nairoukh 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.
- Background: PubMed 31880380Shroff 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.
- Individual participant dataSharing planned: Yes. Individual patient data including demographics, cardiac history indications for cardiac catheterization and all follow up data related to primary outcome, secondary ultrasound endpoints, interventional endpoints and secondary functional outcomes will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dTRA and fTRA in people with Transradial Access and Coronary Angiography, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery intimal medial thickness following dTRA and fTRA (time frame: 90 days post-cardiac catheterization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801901, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.