The TENDERA Multicenter Clinical Trial

Artery; Thrombosis Clinical Trial

— TDR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211584
• Other study ID #: TEN-001/18
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: October 28, 2022

Study information

• Verified date: November 2022
• Source: Center of Endosurgery and Lithotripsy, Moscow, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: October 28, 2022
• Est. primary completion date: September 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Artery; Thrombosis
• Thrombosis

Intervention

Device:
• transradial interventions
percutaneous coronary interventions in stable patients - diagnostic and treatment

Locations

Country	Name	City	State
Russian Federation	Center of Endosurgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Center of Endosurgery and Lithotripsy, Moscow, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery late occlusion	loss of pulse or absent of artery lumen by ultrasound examonation	1 year
Secondary	vascular access site related complications	hematomas >5cm, bleeding, false aneurism, arterio-venous fistula	1 week, 3 months, 6 moths, 1 year