Peripheral Vascular DiseasesSPOMCIDGWNCT06735846
Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire
A study testing Guide wire in people with Peripheral Vascular Diseases and Coronary Artery Disease, run by DemaxGroup.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Coronary Artery Disease
- What is being tested?
- Guide wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eligible for catheter-based diagnostic or treatment procedure. A representative list of diseases and catheter-based treatments includes:
- Suspicion of obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing Suspicion of peripheral vascular obstructive disease undergoing elective or urgent diagnostic and/or percutaneous therapeutic procedures.
- Palpable pulse of the proximal and distal radial artery on one or both arms
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- Subjects must be suitable for a transfemoral vascular access
- Subjects undergoing elective or urgent percutaneous treatment of symptomatic arterial occlusive disease and intermittent claudication or CLI of the SFA and/or popliteal arteries.
- Subjects with suspected narrowed or blocked arteries in the heart.
Who cannot join
- 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
- Subject has a known allergy to the Guide Wire materials
- Subjects with emergent procedures acute ischemia, aneurysmal disease, common femoral or profunda interventions, or hybrid procedures were excluded.
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- Subjects with severe infections
- Subjects with severe heart failure
- Subjects with severe physical weakness
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Investigation to Evaluate the Safety and Performance of Demax Guide Wire
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.
- Being tested
- Guide wire
- Medical subject headings
- Peripheral Vascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guide wireDevice
Insert 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.
| Study group | Role | What they receive |
|---|---|---|
| Demax Guide Wire | Experimental | The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vasculature or coronary vasculature disease. Receives: Device: Guide wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Freedom from SADEs during the procedure and up to 15 ± 2 days after the procedure.
Measured: up to 15 ± 2 days after the procedure.
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
Measured: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
Secondary outcomes (4)
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.
Measured: 15 ± 2 days after the procedure
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
Measured: 15 ± 2 days after the procedure
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.
Measured: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
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.
Measured: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study startMar 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DemaxGroup
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735846
- Sponsor's protocol ID
- DMK/QS-QP32-QD03.15-TJ
- Acronym
- SPOMCIDGW
- Status last verified
- Dec 2024
- First submitted
- 10 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No