Transradial CatheterizationNCT02697526
Differences in Radial Artery Occlusion From Two Different Compressive Methods Used in Patients in Order to Achieve Homeostasis After Transradial Catheterization and Their Repercussion in Artery Functionality and Hand Mobility
A study testing Terumo and Tensoplast in people with Transradial Catheterization, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transradial Catheterization
- What is being tested?
- Terumo and Tensoplast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to May 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route.
- Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
- Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- Patients that will be able to do the follow up visits at 1 week and 3 month.
- Signature of informed consent
Who cannot join
- Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route.
- Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
- Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- Inability to visit at 1 week and 3 month.
- Impossibility to obtain informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Compression Method After Transradial Catheterization in Radial Artery
The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.
Read the detailed description
Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).
- Conditions
- Transradial Catheterization
- Being tested
- Terumo, Tensoplast
- Keywords
- radial artery, occlusion, functional, complications, consequences
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerumoOther
TensoplastOther
| Study group | Role | What they receive |
|---|---|---|
| Terumo | Other | Patients in this arm will receive Terumo after catheterization Receives: Other: Terumo |
| Tensoplast | Other | Patients in this arm will receive Tensoplast after catheterization Receives: Other: Tensoplast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of radial artery occlusion at baseline (before catheterization)
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Measured: 1 day
Determination of radial artery occlusion after catheterization
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Measured: 1 week
Determination of radial artery occlusion after catheterization
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Measured: 3 month
Secondary outcomes (8)
Anatomic differences in radial and ulnar diameters
Anatomic differences in arterial lumen of radial and ulnar arteries (diameter)
Measured: 3 month
Differences in radial and ulnar blood flow between compression methods
Differences in radial and ulnar blood flow as a consequence of radial occlusion
Measured: 3 month
Differences in functional status at follow between compression groups
Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis.
Measured: 1 day
Differences in functional status at follow between compression groups
Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis.
Measured: 1 week
Differences in functional status at follow between compression groups
Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis.
Measured: 3 month
Differences in functional status between occluded radial cohort and patent radial cohort
Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.
Measured: 1 day
Differences in functional status between occluded radial cohort and patent radial cohort
Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.
Measured: 1 week
Differences in functional status between occluded radial cohort and patent radial cohort
Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)Papers the sponsor has linked to this study.
- Other trials for Transradial CatheterizationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno García del Blanco, MD, PhD, Principal investigator, Hospital Universitari Vall d'Hebron (Barcelona)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697526
- Sponsor's protocol ID
- PR(AG)70/2006
- Status last verified
- Feb 2016
- First submitted
- 23 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Amoroso G, Kiemeneij F. Transradial access for primary percutaneous coronary intervention: the next standard of care? Heart. 2010 Sep;96(17):1341-4. doi: 10.1136/hrt.2010.196824.
PubMed 20801852Amoroso G, Laarman GJ, Kiemeneij F. Overview of the transradial approach in percutaneous coronary intervention. J Cardiovasc Med (Hagerstown). 2007 Apr;8(4):230-7. doi: 10.2459/01.JCM.0000263494.10865.0f.
PubMed 17413298Barbeau GR, Arsenault F, Dugas L, Simard S, Lariviere MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004 Mar;147(3):489-93. doi: 10.1016/j.ahj.2003.10.038.
PubMed 14999199Bassand JP. [Platelet antiaggregation treatment in the aftermath of GUSTO IV, TARGET, TACTICS, and CURE trials]. Rev Esp Cardiol. 2002 Jul;55(7):697-702. doi: 10.1016/s0300-8932(02)76686-4. Spanish.
PubMed 12113695Bassand JP, Afzal R, Eikelboom J, Wallentin L, Peters R, Budaj A, Fox KA, Joyner CD, Chrolavicius S, Granger CB, Mehta S, Yusuf S; OASIS 5 and OASIS 6 Investigators. Relationship between baseline haemoglobin and major bleeding complications in acute coronary syndromes. Eur Heart J. 2010 Jan;31(1):50-8. doi: 10.1093/eurheartj/ehp401. Epub 2009 Oct 12.
PubMed 19825809Biancari F, D'Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010 Apr;159(4):518-31. doi: 10.1016/j.ahj.2009.12.027.
PubMed 20362708Brancati MF, Burzotta F, Coluccia V, Trani C. The occurrence of radial artery occlusion following catheterization. Expert Rev Cardiovasc Ther. 2012 Oct;10(10):1287-95. doi: 10.1586/erc.12.125.
PubMed 23190067Burstein JM, Gidrewicz D, Hutchison SJ, Holmes K, Jolly S, Cantor WJ. Impact of radial artery cannulation for coronary angiography and angioplasty on radial artery function. Am J Cardiol. 2007 Feb 15;99(4):457-9. doi: 10.1016/j.amjcard.2006.08.055. Epub 2006 Dec 20.
PubMed 17293183Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103.
PubMed 2912567Campeau L. Entry sites for coronary angiography and therapeutic interventions: from the proximal to the distal radial artery. Can J Cardiol. 2001 Mar;17(3):319-25.
PubMed 11264565Cardoso CO, Rodrigues LH, Cardoso CR, Yordi LM. Impact of radial artery cannulation on radial artery function. Am J Cardiol. 2007 Aug 15;100(4):743-4. doi: 10.1016/j.amjcard.2007.02.045. Epub 2007 May 25. No abstract available.
PubMed 17697842Cong X, Huang Z, Wu J, Wang J, Wen F, Fang L, Fan M, Liang C. Randomized Comparison of 3 Hemostasis Techniques After Transradial Coronary Intervention. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):445-51. doi: 10.1097/JCN.0000000000000268.
PubMed 26002786Desai ND, Naylor CD, Kiss A, Cohen EA, Feder-Elituv R, Miwa S, Radhakrishnan S, Dubbin J, Schwartz L, Fremes SE; Radial Artery Patency Study Investigators. Impact of patient and target-vessel characteristics on arterial and venous bypass graft patency: insight from a randomized trial. Circulation. 2007 Feb 13;115(6):684-91. doi: 10.1161/CIRCULATIONAHA.105.567495. Epub 2007 Feb 5.
PubMed 17283268Dirksen MT, Ronner E, Laarman GJ, van Heerebeek L, Slagboom T, van der Wieken LR, van der Wouw PA, Kiemeneij F. Early discharge is feasible following primary percutaneous coronary intervention with transradial stent implantation under platelet glycoprotein IIb/IIIa receptor blockade. Results of the AGGRASTENT Trial. J Invasive Cardiol. 2005 Oct;17(10):512-7.
PubMed 16204742DOTTER CT, KRIPPAEHNE WW, JUDKINS MP. TRANSLUMINAL RECANALIZATION AND DILATATION IN ATHEROSCLEROTIC OBSTRUCTION OF FEMORAL POPLITEAL SYSTEM. Am Surg. 1965 Jul;31:453-9. No abstract available.
PubMed 14321155
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Compression Method After Transradial Catheterization in Radial Artery
- ClinicalTrials.gov ID
- NCT02697526
- Acronym / sponsor ID
- PR(AG)70/2006
- Conditions
- Transradial Catheterization
- Keywords
- radial artery, occlusion, functional, complications, consequences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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.
The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.
Detailed description
Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terumo | Other | Other: TerumoPatients in this arm will receive Terumo after catheterization |
| Tensoplast | Other | Other: TensoplastPatients in this arm will receive Tensoplast after catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route.
- Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
- Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- Patients that will be able to do the follow up visits at 1 week and 3 month.
- Signature of informed consent
Key exclusion criteria (5 listed)
- Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route.
- Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
- Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- Inability to visit at 1 week and 3 month.
- Impossibility to obtain informed consent form
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 |
|---|---|---|
| Terumo | Other | Terumo |
| Tensoplast | Other | Tensoplast |
Primary outcome
Determination of radial artery occlusion at baseline (before catheterization)
Time frame: 1 day
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Determination of radial artery occlusion after catheterization
Time frame: 1 week
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Determination of radial artery occlusion after catheterization
Time frame: 3 month
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
8 secondary outcomes
Anatomic differences in radial and ulnar diameters
Time frame: 3 month
Differences in radial and ulnar blood flow between compression methods
Time frame: 3 month
Differences in functional status at follow between compression groups
Time frame: 1 day
Differences in functional status at follow between compression groups
Time frame: 1 week
Differences in functional status at follow between compression groups
Time frame: 3 month
Differences in functional status between occluded radial cohort and patent radial cohort
Time frame: 1 day
Differences in functional status between occluded radial cohort and patent radial cohort
Time frame: 1 week
Differences in functional status between occluded radial cohort and patent radial cohort
Time frame: 3 month
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 3 Mar 2016.
- Background: PubMed 20801852Amoroso G, Kiemeneij F. Transradial access for primary percutaneous coronary intervention: the next standard of care? Heart. 2010 Sep;96(17):1341-4. doi: 10.1136/hrt.2010.196824.
- Background: PubMed 17413298Amoroso G, Laarman GJ, Kiemeneij F. Overview of the transradial approach in percutaneous coronary intervention. J Cardiovasc Med (Hagerstown). 2007 Apr;8(4):230-7. doi: 10.2459/01.JCM.0000263494.10865.0f.
- Background: PubMed 14999199Barbeau GR, Arsenault F, Dugas L, Simard S, Lariviere MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004 Mar;147(3):489-93. doi: 10.1016/j.ahj.2003.10.038.
- Background: PubMed 12113695Bassand JP. [Platelet antiaggregation treatment in the aftermath of GUSTO IV, TARGET, TACTICS, and CURE trials]. Rev Esp Cardiol. 2002 Jul;55(7):697-702. doi: 10.1016/s0300-8932(02)76686-4. Spanish.
- Background: PubMed 19825809Bassand JP, Afzal R, Eikelboom J, Wallentin L, Peters R, Budaj A, Fox KA, Joyner CD, Chrolavicius S, Granger CB, Mehta S, Yusuf S; OASIS 5 and OASIS 6 Investigators. Relationship between baseline haemoglobin and major bleeding complications in acute coronary syndromes. Eur Heart J. 2010 Jan;31(1):50-8. doi: 10.1093/eurheartj/ehp401. Epub 2009 Oct 12.
- Background: PubMed 20362708Biancari F, D'Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010 Apr;159(4):518-31. doi: 10.1016/j.ahj.2009.12.027.
- Background: PubMed 23190067Brancati MF, Burzotta F, Coluccia V, Trani C. The occurrence of radial artery occlusion following catheterization. Expert Rev Cardiovasc Ther. 2012 Oct;10(10):1287-95. doi: 10.1586/erc.12.125.
- Background: PubMed 17293183Burstein JM, Gidrewicz D, Hutchison SJ, Holmes K, Jolly S, Cantor WJ. Impact of radial artery cannulation for coronary angiography and angioplasty on radial artery function. Am J Cardiol. 2007 Feb 15;99(4):457-9. doi: 10.1016/j.amjcard.2006.08.055. Epub 2006 Dec 20.
- 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 11264565Campeau L. Entry sites for coronary angiography and therapeutic interventions: from the proximal to the distal radial artery. Can J Cardiol. 2001 Mar;17(3):319-25.
- Background: PubMed 17697842Cardoso CO, Rodrigues LH, Cardoso CR, Yordi LM. Impact of radial artery cannulation on radial artery function. Am J Cardiol. 2007 Aug 15;100(4):743-4. doi: 10.1016/j.amjcard.2007.02.045. Epub 2007 May 25. No abstract available.
- Background: PubMed 26002786Cong X, Huang Z, Wu J, Wang J, Wen F, Fang L, Fan M, Liang C. Randomized Comparison of 3 Hemostasis Techniques After Transradial Coronary Intervention. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):445-51. doi: 10.1097/JCN.0000000000000268.
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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.
Bruno García del Blanco, MD, PhD principal investigator
Hospital Universitari Vall d'Hebron (Barcelona)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terumo and Tensoplast in people with Transradial Catheterization, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 5 inclusion and 5 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 3 Mar 2016. 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 Spain. 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?
Determination of radial artery occlusion at baseline (before catheterization) (time frame: 1 day). The study lists 3 primary outcomes in all. 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 NCT02697526, which also lists 65 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 3 Mar 2016.