Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries

Last updated: February 1, 2023
Sponsor: iVascular S.L.U.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Circulation Disorders

Claudication

Treatment

N/A

Clinical Study ID

NCT05267548
FCRE-211206
  • Ages > 18
  • All Genders

Study Summary

The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Corresponding to the CE-mark indications/contra-indications and according to the IFUof the device.
  2. Patient is >18 years old.
  3. Patient understands the nature of the procedure and provides written informed consentprior to enrolment in the study.
  4. Target lesion(s) is/are located in the popliteal or infrapopliteal arteries
  5. Patient is eligible for treatment with the Oceanus 14pro Balloon Catheter and/or theOceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus ElutingPeripheral Stent System and/or the Sergeant Peripheral Support Catheter as describedin the IFU for each device.

Exclusion

Exclusion Criteria:

  1. Anatomy or size of vessels that will not allow appropriate usage of theinvestigational devices, following IFU of the investigational devices.
  2. Known contraindication and/or allergy to (a component of) an investigational device.
  3. Pregnant women and women with childbearing potential not taking adequatecontraceptives or currently breastfeeding.
  4. Life expectancy of less than 12 months.
  5. Any planned surgical intervention/procedure within 30 days after the study procedure.
  6. Any patient considered to be hemodynamically unstable at onset of procedure.

Study Design

Total Participants: 143
Study Start date:
May 30, 2022
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Imelda Bonheiden

    Bonheiden,
    Belgium

    Active - Recruiting

  • Jessa Hasselt

    Hasselt,
    Belgium

    Active - Recruiting

  • Az Groeninge Kortrijk

    Kortrijk,
    Belgium

    Active - Recruiting

  • Az Sint Maarten Mechelen

    Mechelen,
    Belgium

    Active - Recruiting

  • HH Mol

    Mol,
    Belgium

    Active - Recruiting

  • Az Damiaan Oostende

    Oostende,
    Belgium

    Active - Recruiting

  • RZ Tienen

    Tienen,
    Belgium

    Active - Recruiting

  • Az Jan Portaels Vilvoorde

    Vilvoorde,
    Belgium

    Active - Recruiting

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