The TENDERA Multicenter Clinical Trial

Study Overview
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Brief Summary
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TENDERA is a multicenter randomized controlled trial to compare traditional entry point in the radial artery for TRI and distal puncture at the anatomical snuffbox area for transradial Interventions. The Investigators hypothesized that novel entry point in radial artery may lessen vascular access site complication rate and especially the radial artery late occlusion rate.

Detailed Description
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the forearm access will be made using traditional technique what was well described previously in the literature. The novel puncture site is located in the snuffbox area distal to the traditional radial access point. Thanks to surrounded anatomical conditions in anatomical snuffbox area vascular access site complications may be lessened comparing to forearm radial access site.

Official Title
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Randomized Controlled Trial Comparison Between Traditional ENtry Point and Distal puncturE of RAdial Artery (TENDERA Trial)

Conditions
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Artery; Thrombosis

Intervention / Treatment
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* Device: transradial interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 primary radial artery puncture radial artery diameter >1,5mm by ultrasound stable coronary disease less than 6F sheath needed patient height >185cm Exclusion Criteria: ACS AMI critically ill patients previous TRI procedure Raynaud's disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: forearm radial artery access<br>traditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions | Device: transradial interventions<br>* percutaneous coronary interventions in stable patients - diagnostic and treatment<br>|
| Active Comparator: anatomic snuffbox access<br>access in the snuffbox area of the wrist (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions | Device: transradial interventions<br>* percutaneous coronary interventions in stable patients - diagnostic and treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery late occlusion | loss of pulse or absent of artery lumen by ultrasound examonation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular access site related complications | hematomas >5cm, bleeding, false aneurism, arterio-venous fistula | 1 week, 3 months, 6 moths, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transradial intervention,radial artery,anatomic snuffbox