An interventional study of Use of radial artery for access for a coronary angiography or intervention in Coronary Angiography and Coronary Artery Disease, sponsored by Dr. med. Karsten Schenke. Status unknown at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Dr. med. Karsten Schenke · Not applicable, Interventional, and Treatment
The objective of the study is to determine that a coronary angiography (CAG) or percutaneous coronary intervention (PCI) via a distal puncture of the radial artery (distal transradial access, dTRA) leads to a lower rate of radial artery occlusion (RAO) while also showing that it has a similar success rate when compared to the traditional proximal (proximal transradial access, pTRA) puncture site.
Cardiac catheterization is one of the most common invasive procedures worldwide. After demonstrating the superiority of the radial access over the femoral arterial approach, the radial artery puncture has become the first choice for elective and emergency coronary interventions. In addition to the often chosen access on the inside of the forearm, the course of the radial artery also allows a puncture further distal on the back of the hand. In the anatomical snuffbox, the diameter is still sufficient for the introduction of the usual sheath, however, the thrombogenic puncture at the proximal radial segment is avoided and a hemostasis by compression over the scaphoid is simplified.
This study is a prospective, open-label, randomized, multicenter study to systematically compare primary success rates and potential complications after distal transradial coronary angiography or coronary intervention versus proximal radial artery puncture over the wrist. Both puncture routes are well established in clinical routine and are used in both elective and emergency cardiac catheterization in the centers involved and worldwide. Systematic comparisons exist so far only in small series, but randomized and prospective data would be urgently needed in the frequent application. Both puncture sites are only 4-8 cm apart, so that many risks of a transradial examination (vascular injury and / or closure, perforation, spasm) are in principle common to both access sites.
The purpose of this study is to demonstrate the potential benefits of radial artery puncture in the back of the hand due to a reduced rate of chronic vascular occlusion compared to over the wrist, as well as complications (bleeding or nerve damage) and subjective tolerability ( Pain) systematically.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 500 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
Patients who undergo coronary angiography or intervention by forearm radial artery access
Procedure: Use of radial artery for access for a coronary angiography or intervention
Patients who undergo coronary angiography or intervention by accessing the distal radial artery in the area of the anatomical snuff-box
Procedure: Use of radial artery for access for a coronary angiography or intervention
After puncture of the radial artery in either the area of the anatomical snuffbox or the lower forearm following modified Seldinger technique a sheath will be advanced and a CAG or PCI will be performed. After the procedure is finished the sheath will be withdrawn and a standard closure device will be applied to achieve hemostasis. The choice of the patients side, the sheath, the catheters and the closing device will be at the discretion of the interventionalist.
Lower rate of forearm radial artery occlusion (RAO)
Use of color doppler ultrasound to assess the patency of the radial artery used in the index procedure.
Time frame: 30 days
Puncture success rate of the randomized puncture site
Comparison of the rate of successful Insertion of the sheath in each group
Time frame: During the procedure
Access cross over rate
Comparison of the rate of access site cross over in each group to complete the planned procedure
Time frame: During the procedure
Duration of puncture
Exact measurement of the duration of the puncture in seconds
Time frame: During the procedure
Hematoma, bleeding and other complications
Registration of complications associated with the procedure, hematoma size, bleeding according to the BARC Score
Time frame: 48 hours
Use of standard questionaire to assess pain
Visual analog scale is used to assess pain
Time frame: 30 days
Incidence of vasospasm
The incidence of vasospasm that necessitates additional medication or Forces Access site cross over is registered
Time frame: during the procedure
Use of standard questionaire to assess Hand function
QuickDASH questionaire is used to assess Hand function
Time frame: 30 days
Plan to share: No
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This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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