The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
Study Type
OBSERVATIONAL
Enrollment
60
Hopital Saint Louis
La Rochelle, France
Efficacy endpoint
Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter
Time frame: up to end of procedure
Safety endpoint
Successful balloon dilatation without device related adverse event during the dilatation procedure
Time frame: up to end of procedure
Performance - Pre-dilatation
Residual stenosis \< 50% and TIMI flow grade 3 (corelab assessment)
Time frame: up to end of procedure
Performance - post-dilatation
Angiographic success of the device defined as \< 30% residual stenosis after angiography (corelab assessment)
Time frame: up to end of procedure
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