An interventional study of transradial interventions in Artery; Thrombosis, sponsored by Center of Endosurgery and Lithotripsy, Moscow, Russia. Completed at 1 site in Russia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Center of Endosurgery and Lithotripsy, Moscow, Russia · Not applicable, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Thrombosis; 240 are open to participants now.
This study's enrollment of 850 is above the median of 107 across 866 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →This is the only study on the registry with Center of Endosurgery and Lithotripsy, Moscow, Russia as lead sponsor.
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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
traditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions
Device: transradial 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
Device: transradial interventions
percutaneous coronary interventions in stable patients - diagnostic and treatment
Radial artery late occlusion
loss of pulse or absent of artery lumen by ultrasound examonation
Time frame: 1 year
vascular access site related complications
hematomas \>5cm, bleeding, false aneurism, arterio-venous fistula
Time frame: 1 week, 3 months, 6 moths, 1 year
Plan to share: Yes — all IPD that underlie results
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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