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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Guide wire
DeviceInsert the distal end of the guide wire into the introducer sheath and enter the blood vessel through the introducer sheath;5.Insert the catheter directly into the blood vessel through the guide wire, and when the catheter reaches the target position, exit the guide wire.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Demax Guide WireExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
Freedom from SADEs during the procedure and up to 15 ± 2 days after the procedure.
Time frame
up to 15 ± 2 days after the procedure.2
Primary Performance Endpoint
Successful introduction of Guide Wire and deployment of the intended diagnostic or therapeutic catheter according to the IFU, without any device related deficiencies per insertion attempt
Time frame
Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)Secondary outcomes
1
Rate of Guide Wire deficiencies;
Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. In regard to guide wire deficiencies, once captured, we will compare the rate of guide wire deficiencies to the rates of occurrence outlined within the risk management file to see if they match. If the Guidewire deficiencies are over what is found in the risk management file this could lead to a change in risk mitigation.
Time frame
15 ± 2 days after the procedure2
Rate of complications:
Air embolism, Arteriovenous fistula, Infection, Ischemia, Death, Myocardial infarction, Perforation of the vessel wall, Hematoma at the puncture site, Stroke or system embolization, Thrombus formation, Vascular dissection, Vasospasm
Time frame
15 ± 2 days after the procedure3
Expected number of insertion attempts for a single Guide Wire to reach primary performance endpoint
It is designed to capture the total number of insertion attempts, it can only be qualitative due each procedure being different. Variables for each procedure include (but not limited) the following: Clinical condition of patient, product type used, point of entry site, skill of user.
Time frame
Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)4
Expected time to reach the specified position with the Guide Wire
It is designed to consider the subjective nature of time taken during the procedure, it can only be qualitative due each procedure being different. Variables for each procedure include (but not limited) the following: Clinical condition of patient, product type used, point of entry site, skill of user.
Time frame
Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: