Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire

Launched by DEMAXGROUP · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Demax Guide Wire, which is used in procedures to diagnose and treat conditions affecting blood vessels, such as peripheral vascular diseases and coronary artery disease. The main goal is to check how safe and effective the Guide Wire is when doctors use it to guide other instruments into the blood vessels during these procedures. Researchers want to see if the Guide Wire can be used successfully without problems, how quickly it can reach the correct position in the blood vessel, and how many attempts it takes to do so.

To participate in this study, you must be at least 18 years old and agree to take part. You should be someone who needs a specific procedure using a Guide Wire for conditions like chest pain due to blocked arteries or problems with blood flow in your legs. However, there are certain criteria that could exclude you, such as being pregnant, having a severe infection, or participating in another clinical study. If you decide to join, you can expect to have your safety monitored closely while using the Guide Wire in your procedure, which could help improve treatment options for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age is 18 years old or older
• • 2. Written consent to participate in the study
• • 3. All subjects must be candidates to undergo percutaneous peripheral or coronary diagnostic or interventional procedures where use of a Guide Wire is indicated.
• 4. 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.
• • 5. Palpable pulse of the proximal and distal radial artery on one or both arms
• • 6. Subjects must be suitable for a transfemoral vascular access
• • 7. Subjects undergoing elective or urgent percutaneous treatment of symptomatic arterial occlusive disease and intermittent claudication or CLI of the SFA and/or popliteal arteries.
• • 8. Subjects with suspected narrowed or blocked arteries in the heart.
• Exclusion Criteria:
• • 1. Inability to provide consent
• • 2. Pregnant or lactating women
• • 3. Subjects actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
• • 4. Subjects with bilateral hand or arm misalignment / paresis that makes a radial access impossible
• • 5. Subject has a known allergy to the Guide Wire materials
• • 6. Subjects with emergent procedures acute ischemia, aneurysmal disease, common femoral or profunda interventions, or hybrid procedures were excluded.
• • 7. Subjects with severe infections
• • 8. Subjects with severe heart failure
• • 9. Subjects with severe physical weakness