Ignite Creation Date:
2024-05-06 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05111171
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2021-10-27
Brief Title:
The Guiding Value of Ultrasound and Radial Arteriography in the Selection of Sheath Size for Transradial Coronary Intervention
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 onPrevious studies have found that the mismatch between the radial arterys inner diameter and the sheaths 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 patients radial artery The surgeon is only subjectively based on the patients 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 treatmentThe innovation of this study lies in the use of ultrasound and radial angiography for the measurement of the inner diameter of the patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None