CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CORRECT RADIAL RCT: CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess - a Randomized Trial of Different Radial Puncture Sites

Conditions
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Coronary Angiography, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Use of radial artery for access for a coronary angiography or intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent to participate in the study Age ≥ 18 years Indication for coronary angiography or coronary intervention Palpable pulse of the proximal and distal radial artery on one or both arms Exclusion Criteria: Hemodynamic instability (according to the criteria of cardiogenic shock: Hf> 120 / min and RR syst <90 mmHg) Intubated patients Sonographic evidence of occlusion of both radial arteries Pregnant or lactating women Patients that are currently or have within the last 30 days participated in a clinical trial Primarily planned bilateral radial access; e.g. in the context of a CTO recanalization Patients who are in a dependency / employment/ relationship with the study doctor or center Patients with bilateral hand or arm misalignment / paresis that makes a radial Access impossible Patients who do not speak German or who are unable to understand the nature, significance or scope of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicenter, open Label randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Forearm radial access<br>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<br>* 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.<br>|
| Experimental: Distal radial access<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture success rate of the randomized puncture site | Comparison of the rate of successful Insertion of the sheath in each group | During the procedure | 
| Access cross over rate | Comparison of the rate of access site cross over in each group to complete the planned procedure | During the procedure | 
| Duration of puncture | Exact measurement of the duration of the puncture in seconds | During the procedure | 
| Hematoma, bleeding and other complications | Registration of complications associated with the procedure, hematoma size, bleeding according to the BARC Score | 48 hours | 
| Use of standard questionaire to assess pain | Visual analog scale is used to assess pain | 30 days | 
| Incidence of vasospasm | The incidence of vasospasm that necessitates additional medication or Forces Access site cross over is registered | during the procedure | 
| Use of standard questionaire to assess Hand function | QuickDASH questionaire is used to assess Hand function | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anatomical snuffbox, Percutaneous coronary intervention, Radial access, Distal radial access, Radial artery occlusion, Coronary catheterization, Radial artery