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

NCT04822727 | Withdrawn

• 1 other identifier: FCRE-201016
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iliac Artery Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months.

  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

  Through study completion, an average of 1 year

• Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months

  Through study completion, an average of 1 year

Interventions

1 or more AndraTec devices (see description for list of devices) DEVICE

1 or more AndraTec devices (Lokum L-Quest guidewire, Lokum Amplatz guidewire, Slider Hydrophilic Nitinol Guidewire, AltoSa-XL PTA Balloon, Alto-Sa-XL Gemini Balloon, Optimus-CoCr stent, Optimus-CVS PTFE covered stent)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Dr. Sabrina Overhagen: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Giovanni Torsello, Prof. MD.

  Foundation for Cardiovascular Research and Education

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 30, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share