The TENDERA Multicenter Clinical Trial (TDR)

Center of Endosurgery and Lithotripsy, Moscow, Russia

Status: Completed

Conditions: Artery; Thrombosis

Treatments: Device: transradial interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT04211584

TEN-001/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 850 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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850 participants in 2 patient groups

forearm radial artery access

Active Comparator group

Description:

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

Treatment:

Device: transradial interventions

anatomic snuffbox access

Active Comparator group

Description:

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

Treatment:

Device: transradial interventions