Artery; ThrombosisTDRNCT04211584
The TENDERA Multicenter Clinical Trial
A study testing transradial interventions in people with Artery; Thrombosis, run by Center of Endosurgery and Lithotripsy, Moscow, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Artery; Thrombosis
- What is being tested?
- transradial interventions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteRussia
- Study dates
- 18 Dec 2017to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ACS AMI critically ill patients previous TRI procedure Raynaud's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Artery; Thrombosis
- Being tested
- transradial interventions
- Keywords
- Transradial intervention,radial artery,anatomic snuffbox
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transradial interventionsDevice
percutaneous coronary interventions in stable patients - diagnostic and treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: transradial interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery late occlusion
loss of pulse or absent of artery lumen by ultrasound examonation
Measured: 1 year
Secondary outcomes (1)
vascular access site related complications
hematomas >5cm, bleeding, false aneurism, arterio-venous fistula
Measured: 1 week, 3 months, 6 moths, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start18 Dec 2017
- Primary completion18 Sep 2021
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Artery; ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Endosurgery and Lithotripsy, Moscow, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avtandil M Babunashvili, MD, Principal investigator, Center of EndosurgeryAlexander Kaledin, MD, Principal investigator, North West state University Saint Petersburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211584
- Sponsor's protocol ID
- TEN-001/18
- Acronym
- TDR
- Status last verified
- Nov 2022
- First submitted
- 25 Feb 2018
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results
Publications
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.
PubMed 39474765
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparison Between Traditional ENtry Point and Distal puncturE of RAdial Artery (TENDERA Trial)
- ClinicalTrials.gov ID
- NCT04211584
- Acronym / sponsor ID
- TDR / TEN-001/18
- Conditions
- Artery; Thrombosis
- Keywords
- Transradial intervention,radial artery,anatomic snuffbox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Center of Endosurgery and Lithotripsy, Moscow, RussiaUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| forearm radial artery access | Active comparator | Device: transradial interventionstraditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions |
| anatomic snuffbox access | Active comparator | Device: transradial interventionsaccess 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- ACS AMI critically ill patients previous TRI procedure Raynaud's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transradial interventionspercutaneous coronary interventions in stable patients - diagnostic and treatment | Device | anatomic snuffbox access, forearm radial artery access |
Primary outcome
Radial artery late occlusion
Time frame: 1 year
loss of pulse or absent of artery lumen by ultrasound examonation
1 secondary outcome
vascular access site related complications
Time frame: 1 week, 3 months, 6 moths, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 39474765Babunashvili 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avtandil M Babunashvili, MD principal investigator
Center of Endosurgery
Alexander Kaledin, MD principal investigator
North West state University Saint Petersburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transradial interventions in people with Artery; Thrombosis, run by Center of Endosurgery and Lithotripsy, Moscow, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery late occlusion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.