Randomized Controlled Trial Comparison Between Traditional ENtry Point and Distal puncturE of RAdial Artery (TENDERA Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 850
- Locations
- 1
- Primary Endpoint
- Radial artery late occlusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessor is blinded regarding used access site (traditional radial or Snuffbox approach)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
forearm radial artery access
traditional access (puncture and cannulation) in the forearm part of the radial artery will be made for further coronary interventions
Intervention: transradial interventions (Device)
anatomic snuffbox access
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: transradial interventions (Device)
Outcomes
Primary Outcomes
Radial artery late occlusion
Time Frame: 1 year
loss of pulse or absent of artery lumen by ultrasound examonation
Secondary Outcomes
- vascular access site related complications(1 week, 3 months, 6 moths, 1 year)