The TENDERA Multicenter Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2022-10-28

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.

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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.

Conditions

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Artery; Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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forearm radial artery access

traditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions

Group Type ACTIVE_COMPARATOR

transradial interventions

Intervention Type DEVICE

percutaneous coronary interventions in stable patients - diagnostic and treatment

anatomic snuffbox access

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

Group Type ACTIVE_COMPARATOR

transradial interventions

Intervention Type DEVICE

percutaneous coronary interventions in stable patients - diagnostic and treatment

Interventions

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transradial interventions

percutaneous coronary interventions in stable patients - diagnostic and treatment

Intervention Type DEVICE

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