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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transradial interventions | Device | percutaneous coronary interventions in stable patients - diagnostic and treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radial artery late occlusion | loss of pulse or absent of artery lumen by ultrasound examonation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| vascular access site related complications | hematomas >5cm, bleeding, false aneurism, arterio-venous fistula | 1 week, 3 months, 6 moths, 1 year |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Avtandil M Babunashvili, MD | Center of Endosurgery | Principal Investigator |
| Alexander Kaledin, MD | North West state University Saint Petersburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Endosurgery | Moscow | 111123 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39474765 | Derived | 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. |
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all IPD that underlie results
IV Q of 2021 after the end of the study
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
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 28, 2023 | |
| Reset | Mar 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 28, 2023 | Mar 14, 2024 |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Outcome assessor is blinded regarding used access site (traditional radial or Snuffbox approach)