Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries

NCT05902923 | Recruiting

• 1 other identifier: FCRE-220209
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 6

Brief Summary

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.

Conditions

Artery Disease

Outcome Measures

Primary Outcomes (2)

• Freedeom from SAEs and SADEs (Primary Safety Endpoint)

  Freedeom from SAEs and SADEs

  during procedure and up to 2 years after procedure

• Technical success rate (Primary Efficacy Endpoint)

  Technical success rate defined as ability to cross, introduce and deploy devices based on quantitative scaling by investigators

  during procedure

Secondary Outcomes (5)

• General physician appraisal of the devices by means of rating scale

  during procedure

• General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35

  during procedure

• General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover

  during procedure

• General physician appraisal of the devices by means of rating scale for the Sergeant

  during procedure

• Explorative endpoint

  up to 2 years after procedure

Study Arms (1)

intervention

All patients in the study will undergo same procedure. The implanted devices can be one of more of the study devices.

Procedure: endovascular intervention

Interventions

endovascular intervention PROCEDURE

endovascular intervention

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every patient who is eligible for treatment with any of the following devices, can be considered to be included in the study: the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter

You may qualify if:

• Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
• Patient is \>18 years old.
• Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study.
• Target lesion(s) is/are located in renal, iliac or femoral arteries.
• Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in IFU for each device.

You may not qualify if:

• 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 12 months.
• Any planned surgical intervention/procedure within 30 days after the study procedure.
• Any patient considered to be hemodynamically unstable at onset of the procedure.

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (6)

CH Henri Duffaut

Avignon, France

ACTIVE NOT RECRUITING

Clinique Synergia Ventoux

Carpentras, France

RECRUITING

Polyclinique Inkermann

Niort, France

RECRUITING

L'Hôpital Privé Des Côtes D'Armor

Plérin, France

RECRUITING

Hôpital d'instruction des Armées Sainte Anne

Toulon, France

RECRUITING

Hôpital Privé Toulon Hyeres St. Jean

Toulon, France

RECRUITING

Central Study Contacts

Mieke Ramsdonck

CONTACT

+32 479 64 37 60; mieke.ramsdonck@fcre.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: June 15, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

FR (6)