Back to resultsThe TENDERA Multicenter Clinical Trial (TDR)
Primary Purpose
Artery; Thrombosis
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
transradial interventions
Sponsored by
About this trial
This is an interventional treatment trial for Artery; Thrombosis focused on measuring Transradial intervention,radial artery,anatomic snuffbox
Eligibility Criteria
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
Sites / Locations
- Center of Endosurgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
forearm radial artery access
anatomic snuffbox access
Arm Description
traditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions
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
Outcomes
Primary Outcome Measures
Radial artery late occlusion
loss of pulse or absent of artery lumen by ultrasound examonation
Secondary Outcome Measures
vascular access site related complications
hematomas >5cm, bleeding, false aneurism, arterio-venous fistula
Full Information
NCT ID
NCT04211584
First Posted
February 25, 2018
Last Updated
November 7, 2022
Sponsor
Center of Endosurgery and Lithotripsy, Moscow, Russia
1. Study Identification
Unique Protocol Identification Number
NCT04211584
Brief Title
The TENDERA Multicenter Clinical Trial
Acronym
TDR
Official Title
Randomized Controlled Trial Comparison Between Traditional ENtry Point and Distal puncturE of RAdial Artery (TENDERA Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
September 18, 2021 (Actual)
Study Completion Date
October 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Endosurgery and Lithotripsy, Moscow, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artery; Thrombosis
Keywords
Transradial intervention,radial artery,anatomic snuffbox
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor is blinded regarding used access site (traditional radial or Snuffbox approach)
Allocation
Randomized
Enrollment
850 (Actual)
8. Arms, Groups, and Interventions
Arm Title
forearm radial artery access
Arm Type
Active Comparator
Arm Description
traditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions
Arm Title
anatomic snuffbox access
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
transradial interventions
Intervention Description
percutaneous coronary interventions in stable patients - diagnostic and treatment
Primary Outcome Measure Information:
Title
Radial artery late occlusion
Description
loss of pulse or absent of artery lumen by ultrasound examonation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
vascular access site related complications
Description
hematomas >5cm, bleeding, false aneurism, arterio-venous fistula
Time Frame
1 week, 3 months, 6 moths, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avtandil M Babunashvili, MD
Organizational Affiliation
Center of Endosurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Kaledin, MD
Organizational Affiliation
North West state University Saint Petersburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Endosurgery
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
The TENDERA Multicenter Clinical Trial
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