Clinical trial NCT04822727: AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.
Official title: A Prospective Physician-Initiated PMCF Study Investigating the Safety and Clinical Performance of the Lokum L-Quest Guidewire, the Lokum Amplatz Guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA Balloon, the AltoSa-XL Gemini Balloon Catheter, the Optimus XL CoCr Stent and the Optimus CVS PTFE Covered XL Stent for the Endovascular Intervention
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Iliac Artery Disease
Peripheral Artery Disease
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease, meeting the in/exclusion criteria and eligible for treatment with the AndraTec devices, according to the IFU of each device.

Brief summary: 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.


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

Primary outcomes:
measure: Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure
timeFrame: during procedure
measure: Technical success rate
timeFrame: during procedure
Secondary outcomes:
measure: For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months.
timeFrame: Through study completion, an average of 1 year
measure: For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from Device-related serious adverse events (SAE's) post-procedure, after 6- and 12-months
timeFrame: Through study completion, an average of 1 year
measure: Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Foundation for Cardiovascular Research and Education
name: Giovanni Torsello, Prof. MD.
role: STUDY_DIRECTOR
References: