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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Peripheral Artery Disease; Iliac Artery Disease
• Intervention / Treatment: Device: 1 or more AndraTec devices (see description for list of devices)

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure	MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)	during procedure
Technical success rate	defined as successfully introduction and deployment of the Lokum L-Quest, and/or the Lokum Amplatz, and/or the Slider Hydrophilic Nitinol Guidewire, and/or the Optimus CoCr Stent, and/or the Optimus PFTE covered BE Stent, and/or the AltoSa-XL-PTA, and/or the AltoSa-XL-Gemini Balloon Catheter according to the respective IFU and without device related deficiencies.	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months.	MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)	Through study completion, an average of 1 year
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	Freedom from Device-Related serious adverse events (SAE's)	Through study completion, an average of 1 year
Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months	Defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Dr. Sabrina Overhagen
• Investigators: Study Director: Giovanni Torsello, Prof. MD., Foundation for Cardiovascular Research and Education

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2021
• Primary Completion (Estimated): December 31, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: FCRE-201016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No