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

Sponsor
Prof. Giovanni Torsello (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04822727
Collaborator
(none)
200
32

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 1 or more AndraTec devices (see description for list of devices)

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure [during 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)

  2. Technical success rate [during procedure]

    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.

Secondary Outcome Measures

  1. 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]

    MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)

  2. 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 Device-Related serious adverse events (SAE's)

  3. Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months [Through study completion, an average of 1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Prof. Giovanni Torsello

Investigators

  • Study Director: Giovanni Torsello, Prof. MD., Foundation for Cardiovascular Research and Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Giovanni Torsello, Study Director, FCRE (Foundation for Cardiovascular Research and Education)
ClinicalTrials.gov Identifier:
NCT04822727
Other Study ID Numbers:
  • FCRE-201016
First Posted:
Mar 30, 2021
Last Update Posted:
Mar 30, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 30, 2021