Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
Recruiting
Observational Study
Artery Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
209 (estimated)
Sponsor
iVascular S.L.U. · Industry
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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