Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDemaxGroup
About this trial
The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vascular or coronary vascular disease for diagnostic or treatment procedures and will be the pivotal trial for this device. This study intends to evaluate the Guide Wire in its ability to successfully deploy an intended diagnostic or therapeutic catheter according to the IFU without any device related deficiencies, time to reach a specified position, and total number of insertion attempts to reach a primary performance endpoint.
Eligibility criteria
Qualifiers
Age is 18 years old or older
Written consent to participate in the study
All subjects must be candidates to undergo percutaneous peripheral or coronary diagnostic or interventional procedures where use of a Guide Wire is indicated.
Palpable pulse of the proximal and distal radial artery on one or both arms
Disqualifiers
Inability to provide consent
Pregnant or lactating women
Subjects actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
Subjects with bilateral hand or arm misalignment / paresis that makes a radial access impossible
Trial design
Treatments tested in this trial
- Guide wire
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov