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OpenTrials
Completed

NCT Number: NCT04211584

The TENDERA Multicenter Clinical Trial

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.

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Key information

Conditions

Artery; Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Endosurgery

Moscow, 111123, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transradial interventions

Device

percutaneous coronary interventions in stable patients - diagnostic and treatment

Primary outcomes

  1. Radial artery late occlusion

    Time frame: 1 year

    loss of pulse or absent of artery lumen by ultrasound examonation

Secondary outcomes

  1. vascular access site related complications

    Time frame: 1 week, 3 months, 6 moths, 1 year

    hematomas >5cm, bleeding, false aneurism, arterio-venous fistula

Sponsors and collaborators

Lead sponsor

Center of Endosurgery and Lithotripsy, Moscow, Russia

Other

Registry information

Official study title

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

Acronym: TDR

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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