Actively Recruiting
Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
Led by iVascular S.L.U. · Updated on 2024-05-08
209
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is older than 18 years.
- Patient understands the procedure and gives written informed consent before joining the study.
- Target lesions are located in the renal, iliac, or femoral arteries.
- Patient is eligible for treatment with one or more of the investigational devices as described in their instructions for use.
You will not qualify if you...
- Vessel anatomy or size does not allow proper use of the investigational devices according to instructions.
- Known allergy or contraindication to any component of the investigational devices.
- Pregnant women, breastfeeding women, or women with childbearing potential not using adequate contraception.
- Life expectancy less than 12 months.
- Planned surgery or procedure within 30 days after the study procedure.
- Patient is hemodynamically unstable at the start of the procedure.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
CH Henri Duffaut
Avignon, France
Active, Not Recruiting
2
Clinique Synergia Ventoux
Carpentras, France
Actively Recruiting
3
Polyclinique Inkermann
Niort, France
Actively Recruiting
4
L'Hôpital Privé Des Côtes D'Armor
Plérin, France
Actively Recruiting
5
Hôpital d'instruction des Armées Sainte Anne
Toulon, France
Actively Recruiting
6
Hôpital Privé Toulon Hyeres St. Jean
Toulon, France
Actively Recruiting
Research Team
M
Mieke Ramsdonck
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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