Coronary Artery DiseaseNCT05111171
The Guiding Value of Ultrasound and Radial Arteriography in the Selection of Sheath Size for Transradial Coronary Intervention
An observational study of Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Coronary angiography is a relatively safe and reliable invasive diagnostic technique, clinically considered the "gold standard" for diagnosing coronary heart disease. In 1989, Canadian doctor Campeau performed trans-radial angiography (TRA) for the first time percutaneous puncture of the radial artery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- sheath
- Type of treatment
- Medical device
- How many people
- 501 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2021to 31 Dec 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study adopts a continuous enrollment method. It is estimated that 500 patients will be enrolled within the study period.
Who may be able to join
- Those who are diagnosed or suspected of having coronary heart disease;
- Patients undergoing first time selective interventional surgery via the right radial artery;
- Those who can understand the purpose of this experiment, participate in this study voluntarily, and sign an informed consent form.
Who cannot join
- Have a history of PCI through the right radial artery;
- Those with deformity, trauma, or amputation of the right upper limb;
- Those who have negative Allen's test;
- There are other contraindications to coronary angiography surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Guiding Value of Ultrasound and Radial Arteriography in the Selection of Sheath Size for Transradial Coronary Intervention: A Single-center Clinical Study
Coronary angiography is a relatively safe and reliable invasive diagnostic technique, clinically considered the "gold standard" for diagnosing coronary heart disease. In 1989, Canadian doctor Campeau performed trans-radial angiography (TRA) for the first time percutaneous puncture of the radial artery. In 1993, Dutch doctor Keimeneij and others completed the first trans-radial coronary intervention (trans-radial intervention, TRI) . After nearly 30 years of clinical practice, the radial artery approach has become the first choice for coronary intervention and treatment. Compared with the femoral artery approach, the radial artery approach has the advantages of fewer traumas, less risk of bleeding, shorter hospital stay, and patients' early mobility. However, there are also few disadvantages of the radial access, such as small inner diameter, repeated puncture prone to spasm, limiting the implantation of larger sheaths to treat complex coronary artery diseases and postoperative complications such as thickening and stenosis and occlusion of the radial artery. The incidence is higher, and so on.Previous studies have found that the mismatch between the radial artery's inner diameter and the sheath's diameter is an essential factor that causes complications such as thickening, stenosis, and occlusion of the radial artery after intervention. Patients with coronary heart disease often need to repeat coronary interventional examinations and treatments. To ensure the radial artery route and avoid complications such as radial artery occlusion (RAO) after intervention for repeated use. It is worthy of attention. At present, in clinical ascending coronary angiography (CAG) or coronary interventional therapy (PCI), most of the radial artery sheath sizes are not selected according to the diameter of the patient's radial artery. The surgeon is only subjectively based on the patient's radial artery pulsation strength and coronary artery pulsation. It depends on the complexity of the pulse pathology. The incidence of radial artery occlusion reported in previous studies is 5%-38%. Most of these studies only rely on clinical forearm examination and pulse palpation without vascular ultrasound, radial angiography, and other imaging examinations to assess catheter placement. The degree of patency of the posterior radial artery has caused considerable differences in the reported incidence of radial artery occlusion. However, PCI treatment of complex lesions such as bifurcation, high calcification, severe distortion, chronic total occlusion, etc., usually requires a 7F sheath to provide better support and convenient equipment delivery. Still, the latter has the following problems: on the one hand, patients' pain, vasospasm, and other reasons can easily lead to failure of the radial artery sheath grafting; on the other hand, although the 7F sheath is used to complete PCI for complex lesions, the postoperative Radial artery occlusion is prone to occur, resulting in long-term failure to undergo re-radial artery angiography or PCI treatment.The innovation of this study lies in the use of ultrasound and radial angiography for the measurement of the inner diameter of the patient's radial artery, to examine the distribution of the inner diameter of the radial artery, and to predict the cut-off value of the radial artery inner diameter for successful sheath implantation and the inner diameter resection of the radial artery occlusion after the operation. The point value provides an evidence-based basis for selecting the sheath size of the radial artery in the future to achieve the clinical purpose of protecting the radial artery for repeated use.
- Conditions
- Coronary Artery Disease
- Being tested
- sheath
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sheathDevice
Senior interventional doctors interpret the CAG results and group according to their clinical experience: (1) No PCI is required, only diagnostic CAG is required, which is group ①6F sheath CAG group; (2) PCI is required, simple lesions are group ②6F sheath PCI group, the 6F sheath is still used for PCI; (3) PCI is required for the complicated disease and use 7F sheath, as the 7F sheath PCI group is the group ③, and the 7F sheath is replaced for PCI.
| Study group | Role | What they receive |
|---|---|---|
| 6F sheath CAG group | No PCI is required, only diagnostic CAG is required. Receives: Device: sheath | |
| 6F sheath PCI group | PCI is required, simple lesions are group. Receives: Device: sheath | |
| 7F sheath PCI group | PCI is required for the complicated disease. Receives: Device: sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cut-off value of the radial artery inner diameter, successfully implanted with 6F and 7F sheath.
Measured: 30days
The cut-off value of the radial artery diameter, at which the radial artery occlusion occurred in the 6F and 7F sheath groups.
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start6 Jan 2021
- Primary completion17 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111171
- Sponsor's protocol ID
- 017
- Status last verified
- Jan 2023
- First submitted
- 27 Oct 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 2912567Kiemeneij F, Laarman GJ. Transradial artery Palmaz-Schatz coronary stent implantation: results of a single-center feasibility study. Am Heart J. 1995 Jul;130(1):14-21. doi: 10.1016/0002-8703(95)90229-5.
PubMed 7611104Rao SV, Cohen MG, Kandzari DE, Bertrand OF, Gilchrist IC. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. J Am Coll Cardiol. 2010 May 18;55(20):2187-95. doi: 10.1016/j.jacc.2010.01.039.
PubMed 20466199Kanei Y, Kwan T, Nakra NC, Liou M, Huang Y, Vales LL, Fox JT, Chen JP, Saito S. Transradial cardiac catheterization: a review of access site complications. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):840-6. doi: 10.1002/ccd.22978. Epub 2011 May 12.
PubMed 21567879Pancholy 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.
PubMed 18726956Stella PR, Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. Incidence and outcome of radial artery occlusion following transradial artery coronary angioplasty. Cathet Cardiovasc Diagn. 1997 Feb;40(2):156-8. doi: 10.1002/(sici)1097-0304(199702)40:23.0.co;2-a.
PubMed 9047055Sanmartin M, Gomez M, Rumoroso JR, Sadaba M, Martinez M, Baz JA, Iniguez A. Interruption of blood flow during compression and radial artery occlusion after transradial catheterization. Catheter Cardiovasc Interv. 2007 Aug 1;70(2):185-9. doi: 10.1002/ccd.21058.
PubMed 17203470Cubero JM, Lombardo J, Pedrosa C, Diaz-Bejarano D, Sanchez B, Fernandez V, Gomez C, Vazquez R, Molano FJ, Pastor LF. Radial compression guided by mean artery pressure versus standard compression with a pneumatic device (RACOMAP). Catheter Cardiovasc Interv. 2009 Mar 1;73(4):467-72. doi: 10.1002/ccd.21900.
PubMed 19229978Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.
PubMed 19081409Yan ZX, Zhou YJ, Zhao YX, Zhou ZM, Yang SW, Wang ZJ. Anatomical study of forearm arteries with ultrasound for percutaneous coronary procedures. Circ J. 2010 Apr;74(4):686-92. doi: 10.1253/circj.cj-09-0577. Epub 2010 Mar 3.
PubMed 20197630Uhlemann M, Mobius-Winkler S, Mende M, Eitel I, Fuernau G, Sandri M, Adams V, Thiele H, Linke A, Schuler G, Gielen S. The Leipzig prospective vascular ultrasound registry in radial artery catheterization: impact of sheath size on vascular complications. JACC Cardiovasc Interv. 2012 Jan;5(1):36-43. doi: 10.1016/j.jcin.2011.08.011.
PubMed 22230148
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Guiding Value of Ultrasound and Radial Arteriography in the Selection of Sheath Size for Transradial Coronary Intervention: A Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT05111171
- Acronym / sponsor ID
- 017
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Nov 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.
Coronary angiography is a relatively safe and reliable invasive diagnostic technique, clinically considered the "gold standard" for diagnosing coronary heart disease. In 1989, Canadian doctor Campeau performed trans-radial angiography (TRA) for the first time percutaneous puncture of the radial artery. In 1993, Dutch doctor Keimeneij and others completed the first trans-radial coronary intervention (trans-radial intervention, TRI) . After nearly 30 years of clinical practice, the radial artery approach has become the first choice for coronary intervention and treatment. Compared with the femoral artery approach, the radial artery approach has the advantages of fewer traumas, less risk of bleeding, shorter hospital stay, and patients' early mobility. However, there are also few disadvantages of the radial access, such as small inner diameter, repeated puncture prone to spasm, limiting the implantation of larger sheaths to treat complex coronary artery diseases and postoperative complications such as thickening and stenosis and occlusion of the radial artery. The incidence is higher, and so on.Previous studies have found that the mismatch between the radial artery's inner diameter and the sheath's diameter is an essential factor that causes complications such as thickening, stenosis, and occlusion of the radial artery after intervention. Patients with coronary heart disease often need to repeat coronary interventional examinations and treatments. To ensure the radial artery route and avoid complications such as radial artery occlusion (RAO) after intervention for repeated use. It is worthy of attention. At present, in clinical ascending coronary angiography (CAG) or coronary interventional therapy (PCI), most of the radial artery sheath sizes are not selected according to the diameter of the patient's radial artery. The surgeon is only subjectively based on the patient's radial artery pulsation strength and coronary artery pulsation. It depends on the complexity of the pulse pathology. The incidence of radial artery occlusion reported in previous studies is 5%-38%. Most of these studies only rely on clinical forearm examination and pulse palpation without vascular ultrasound, radial angiography, and other imaging examinations to assess catheter placement. The degree of patency of the posterior radial artery has caused considerable differences in the reported incidence of radial artery occlusion. However, PCI treatment of complex lesions such as bifurcation, high calcification, severe distortion, chronic total occlusion, etc., usually requires a 7F sheath to provide better support and convenient equipment delivery. Still, the latter has the following problems: on the one hand, patients' pain, vasospasm, and other reasons can easily lead to failure of the radial artery sheath grafting; on the other hand, although the 7F sheath is used to complete PCI for complex lesions, the postoperative Radial artery occlusion is prone to occur, resulting in long-term failure to undergo re-radial artery angiography or PCI treatment.The innovation of this study lies in the use of ultrasound and radial angiography for the measurement of the inner diameter of the patient's radial artery, to examine the distribution of the inner diameter of the radial artery, and to predict the cut-off value of the radial artery inner diameter for successful sheath implantation and the inner diameter resection of the radial artery occlusion after the operation. The point value provides an evidence-based basis for selecting the sheath size of the radial artery in the future to achieve the clinical purpose of protecting the radial artery for repeated use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6F sheath CAG group | – | Device: sheathNo PCI is required, only diagnostic CAG is required. |
| 6F sheath PCI group | – | Device: sheathPCI is required, simple lesions are group. |
| 7F sheath PCI group | – | Device: sheathPCI is required for the complicated disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study adopts a continuous enrollment method. It is estimated that 500 patients will be enrolled within the study period.
Key inclusion criteria (3 listed)
- Those who are diagnosed or suspected of having coronary heart disease;
- Patients undergoing first time selective interventional surgery via the right radial artery;
- Those who can understand the purpose of this experiment, participate in this study voluntarily, and sign an informed consent form.
Key exclusion criteria (4 listed)
- Have a history of PCI through the right radial artery;
- Those with deformity, trauma, or amputation of the right upper limb;
- Those who have negative Allen's test;
- There are other contraindications to coronary angiography surgery.
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 |
|---|---|---|
| sheathSenior interventional doctors interpret the CAG results and group according to their clinical experience: (1) No PCI is required, only diagnostic CAG is required, which is group ①6F sheath CAG group; (2) PCI is required, simple lesions are group ②6F sheath PCI group, the 6F sheath is still used for PCI; (3) PCI is required for the complicated disease and use 7F sheath, as the 7F sheath PCI group is the group ③, and the 7F sheath is replaced for PCI. | Device | 6F sheath CAG group, 6F sheath PCI group, 7F sheath PCI group |
Primary outcome
The cut-off value of the radial artery inner diameter, successfully implanted with 6F and 7F sheath.
Time frame: 30days
The cut-off value of the radial artery diameter, at which the radial artery occlusion occurred in the 6F and 7F sheath groups.
Time frame: 30days
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 10 Jan 2023.
- Results publication: PubMed 2912567Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103.
- Results publication: PubMed 7611104Kiemeneij F, Laarman GJ. Transradial artery Palmaz-Schatz coronary stent implantation: results of a single-center feasibility study. Am Heart J. 1995 Jul;130(1):14-21. doi: 10.1016/0002-8703(95)90229-5.
- Results publication: PubMed 20466199Rao SV, Cohen MG, Kandzari DE, Bertrand OF, Gilchrist IC. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. J Am Coll Cardiol. 2010 May 18;55(20):2187-95. doi: 10.1016/j.jacc.2010.01.039.
- Results publication: PubMed 21567879Kanei Y, Kwan T, Nakra NC, Liou M, Huang Y, Vales LL, Fox JT, Chen JP, Saito S. Transradial cardiac catheterization: a review of access site complications. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):840-6. doi: 10.1002/ccd.22978. Epub 2011 May 12.
- Results publication: PubMed 18726956Pancholy 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.
- Results publication: PubMed 9047055Stella PR, Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. Incidence and outcome of radial artery occlusion following transradial artery coronary angioplasty. Cathet Cardiovasc Diagn. 1997 Feb;40(2):156-8. doi: 10.1002/(sici)1097-0304(199702)40:23.0.co;2-a.
- Results publication: PubMed 17203470Sanmartin M, Gomez M, Rumoroso JR, Sadaba M, Martinez M, Baz JA, Iniguez A. Interruption of blood flow during compression and radial artery occlusion after transradial catheterization. Catheter Cardiovasc Interv. 2007 Aug 1;70(2):185-9. doi: 10.1002/ccd.21058.
- Results publication: PubMed 19229978Cubero JM, Lombardo J, Pedrosa C, Diaz-Bejarano D, Sanchez B, Fernandez V, Gomez C, Vazquez R, Molano FJ, Pastor LF. Radial compression guided by mean artery pressure versus standard compression with a pneumatic device (RACOMAP). Catheter Cardiovasc Interv. 2009 Mar 1;73(4):467-72. doi: 10.1002/ccd.21900.
- Results publication: PubMed 19081409Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.
- Results publication: PubMed 20197630Yan ZX, Zhou YJ, Zhao YX, Zhou ZM, Yang SW, Wang ZJ. Anatomical study of forearm arteries with ultrasound for percutaneous coronary procedures. Circ J. 2010 Apr;74(4):686-92. doi: 10.1253/circj.cj-09-0577. Epub 2010 Mar 3.
- Results publication: PubMed 22230148Uhlemann M, Mobius-Winkler S, Mende M, Eitel I, Fuernau G, Sandri M, Adams V, Thiele H, Linke A, Schuler G, Gielen S. The Leipzig prospective vascular ultrasound registry in radial artery catheterization: impact of sheath size on vascular complications. JACC Cardiovasc Interv. 2012 Jan;5(1):36-43. doi: 10.1016/j.jcin.2011.08.011.
- Individual participant dataSharing planned: No
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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?
An observational study of Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 10 Jan 2023. 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 China. 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?
The cut-off value of the radial artery inner diameter, successfully implanted with 6F and 7F sheath. (time frame: 30days). The study lists 2 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 NCT05111171, which also lists 11 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 10 Jan 2023.