AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.

Dr. Sabrina Overhagen

Status: Withdrawn

Conditions: Peripheral Artery Disease; Iliac Artery Disease

Treatments: Device: 1 or more AndraTec devices (see description for list of devices)

Study type: Observational

Funder types: Other

Identifiers

NCT04822727

FCRE-201016

Details and patient eligibility

About

This PMCF study is designed as prospective, multi-center study to collect real-life data.

The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used:

The LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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