The TENDERA Multicenter Clinical Trial

NCT04211584 | Completed DMC

• 1 other identifier: TEN-001/18
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Artery; Thrombosis

Keywords

Transradial intervention,radial artery,anatomic snuffbox

Outcome Measures

Primary Outcomes (1)

• Radial artery late occlusion

  loss of pulse or absent of artery lumen by ultrasound examonation

  1 year

Secondary Outcomes (1)

• vascular access site related complications

  1 week, 3 months, 6 moths, 1 year

Study Arms (2)

forearm radial artery access

ACTIVE COMPARATOR

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

Device: transradial interventions

anatomic snuffbox access

ACTIVE COMPARATOR

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

Interventions

transradial interventions DEVICE

percutaneous coronary interventions in stable patients - diagnostic and treatment

anatomic snuffbox access; forearm radial artery access

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ACS AMI critically ill patients previous TRI procedure Raynaud's disease

Sponsors & Collaborators

• Center of Endosurgery and Lithotripsy, Moscow, Russia: lead

Study Sites (1)

Center of Endosurgery

Moscow, 111123, Russia

Location

Related Publications (1)

• Babunashvili AM, Pancholy S, Zulkarnaev AB, Kaledin AL, Kochanov IN, Korotkih AV, Kartashov DS, Babunashvili MA. Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study. Catheter Cardiovasc Interv. 2024 Dec;104(7):1396-1405. doi: 10.1002/ccd.31271. Epub 2024 Oct 30.

  PMID: 39474765 DERIVED

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Avtandil M Babunashvili, MD

  Center of Endosurgery

  PRINCIPAL INVESTIGATOR

• Alexander Kaledin, MD

  North West state University Saint Petersburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor is blinded regarding used access site (traditional radial or Snuffbox approach)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: December 26, 2019
• Study Start: December 18, 2017
• Primary Completion: September 18, 2021
• Study Completion: October 28, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IV Q of 2021 after the end of the study
• 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

Locations

RU (1)