The TENDERA Multicenter Clinical Trial (TDR)

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

Study Overview

• Status: Completed
• Conditions: Artery; Thrombosis
• Intervention / Treatment: Device: transradial interventions

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.

• Study Type: Interventional
• Enrollment (Actual): 850
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 111123
    • Center of Endosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: forearm radial artery access; traditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions	Device: transradial interventions; percutaneous coronary interventions in stable patients - diagnostic and treatment
Active Comparator: 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	Device: transradial interventions; percutaneous coronary interventions in stable patients - diagnostic and treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Center of Endosurgery and Lithotripsy, Moscow, Russia
• Investigators: Principal Investigator: Avtandil M Babunashvili, MD, Center of Endosurgery; Principal Investigator: Alexander Kaledin, MD, North West state University Saint Petersburg

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): September 18, 2021
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Transradial intervention,radial artery,anatomic snuffbox
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: TEN-001/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results
• IPD Sharing Time Frame: IV Q of 2021 after the end of the study
• IPD Sharing Access Criteria: IPD may be requested by interventional cardiologists or radiologists IPD information may be shared after a request from individual or academic organizations if some concern and questions will raised
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No