Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT04822727
Eligibility Criteria:
Inclusion Criteria:
\- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is \>18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with
* the Lokum L-Quest guidewire
* and/or the Lokum Amplatz guidewire
* and/or the Slider Hydrophilic Nitinol Guidewire
* and/or the AltoSa-XL PTA balloon
* and/or the AltoSa-XL Gemini balloon catheter
* and/or the Optimus-XL CoCr Bare Metal Stent
* and/or the Optimus-XL CVS PTFE Covered Stent, as described in the IFU for each device.
Exclusion Criteria:
* Application in coronary, cerebral arteries and central circulatory system
* Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
* Known contraindication and/or allergy to (a component of) an investigational device
* Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding
* Life expectancy of less than twelve months
* Any planned surgical intervention/procedure within 30 days of the study procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Patient is currently participating in another investigational drug or device study that has not completed the entire follow-up period.
Device-related exclusion criteria (not applicable for guidewire):
* Known contraindications given in the IFU of Optimus CoCr and Optimus-CVS PTFE- Covered Balloon-Expandable Stent which includes treatment of renal arteries, aneurysms adjacent to site of stent implantation and neurovascular treatment
* Known contraindications given in the IFU of AltoSa-XL-PTA and AltoSa-XL-Gemini Balloon catheter:
* patients with a contraindication for anti-platelet/anti-coagulant therapy
* patients with excessive vessel tortuosity
* dilatation of in-stent restenosis and highly calcified stenosis
* patients with perforated vessels evidenced by extravasation of contrast media
* patients with a known hypersensitivity to nylon
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04822727
Study Brief:
Protocol Section:
NCT04822727