CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 501 enrolled
Drug / intervention
sheathdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05111171
NCT05111171N/ACompleted

The Guiding Value of Ultrasound and Radial Arteriography in the Selection of Sheath Size for Transradial Coronary Intervention: A Single-center Clinical Study

The First Affiliated Hospital with Nanjing Medical University·observational·Posted Nov 8, 2021·Updated Jan 10, 2023

In Brief

An observational study evaluating sheath for Coronary Artery Disease. Completed, enrolled 501 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 8, 2021
Enrollment StartJan 6, 2021
Primary CompletionOct 17, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.6 years ago

Interventions

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.