This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.
Study Type
OBSERVATIONAL
Enrollment
25
Stenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access
Vascular center of Klinikum Hochsauerland GmbH
Arnsberg, Germany
Access site complications
bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion
Time frame: 1 hour post procedure
Stroke
Time frame: 30 days
Death
Time frame: 30 days
Transradial technical success
Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30%
Time frame: Immediately after stent placement via radial access
Number of patients converting to femoral artery access
Transradial access feasibility is assessed as number of patients in whom access is converted to femoral artery access due to failure to access the lesion via the radial artery
Time frame: 1 hour post procedure
Length of hospital stay [hours]
Time frame: up to 30 days
Procedure time [min]
Time frame: Intraoperative
Procedure cost
Number and details of auxiliary devices and medication used
Time frame: 1 hour post procedure
Time to ambulation
Time between patient left the cath lab/operating theatre, and patient was able to walk 100 meters and the access site remained stable
Time frame: up to 30 days
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Patient satisfaction regarding access site
Patient questionnaire assessing 8 questions (anxiety about the procedure, overall pain, back pain, difficulties in toiletting, walking, daily movement, selfcare and using the dominant hand) on a numeric rating scale (NRS, 0-10, 0 = none, 10 most severe).
Time frame: 24 hours post procedure