The TENDERA Multicenter Clinical Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04211584

Acronym

TDR

Enrollment

850

Registered

2019-12-26

Start date

2017-12-18

Completion date

2022-10-28

Last updated

2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artery; Thrombosis

Keywords

Transradial intervention,radial artery,anatomic snuffbox

Brief summary

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

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.

Interventions

DEVICEtransradial interventions

percutaneous coronary interventions in stable patients - diagnostic and treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Outcome assessor is blinded regarding used access site (traditional radial or Snuffbox approach)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Radial artery late occlusion	1 year	loss of pulse or absent of artery lumen by ultrasound examonation

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026