NCT06735846Not yet recruiting
Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire
Clinical Investigation to Evaluate the Safety and Performance of Demax Guide Wire
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 10 Nov 2024
- Start date
- Mar 2025
- Primary completion date
- Jun 2025
- Lead sponsor
- DemaxGroup
- Diseases
- Coronary artery disease
- NCT number
- NCT06735846
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Mar 2025 to the primary completion date, Jun 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
Other illness
- 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.
- Subjects with severe infections
- Subjects with severe heart failure
Other
- Inability to provide consent
- Pregnant or lactating women
- Subjects with bilateral hand or arm misalignment / paresis that makes a radial access impossible
- Subjects with severe physical weakness
Who the study is looking for
- 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
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.