The Guiding Value of Ultrasound and Radial Arteriography in the Selection of Sheath Size for Transradial Coronary Intervention

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111171
• Other study ID #: 017
• Status: Completed
• Start date: January 6, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: December 31, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Those who are diagnosed or suspected of having coronary heart disease;

2. Patients undergoing first time selective interventional surgery via the right radial artery;

3. Those who can understand the purpose of this experiment, participate in this study voluntarily, and sign an informed consent form.

Exclusion Criteria:

1. Have a history of PCI through the right radial artery;

2. Those with deformity, trauma, or amputation of the right upper limb;

3. Those who have negative Allen's test;

4. There are other contraindications to coronary angiography surgery.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• sheath
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 ?6F sheath CAG group; (2) PCI is required, simple lesions are group ?6F 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 ?, and the 7F sheath is replaced for PCI.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (11)

Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103. — View Citation

Cubero 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 Inter — View Citation

Jolly 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;15 — View Citation

Kanei 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. — View Citation

Kiemeneij 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. — 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. Cathete — View Citation

Rao 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.2 — View Citation

Sanmartin 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.2 — View Citation

Stella 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( — View Citation

Uhlemann 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. J — View Citation

Yan 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cut-off value of the radial artery inner diameter, successfully implanted with 6F and 7F sheath.		30days
Primary	The cut-off value of the radial artery diameter, at which the radial artery occlusion occurred in the 6F and 7F sheath groups.		30days