Actively Recruiting
Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
Led by Translumina GmbH · Updated on 2024-06-06
3000
Participants Needed
19
Research Sites
161 weeks
Total Duration
On this page
Sponsors
T
Translumina GmbH
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
CONDITIONS
Official Title
Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Ability to provide signed informed consent form
- Male or non-pregnant female patient (pregnancy status to be confirmed verbally if female of reproductive age)
- Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or positive noninvasive test for ischemia or evidence of functionally significant coronary stenosis
- Patient having social security number
- Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting
You will not qualify if you...
- Concurrent participation in another clinical trial
- Having received an angioplasty with a stent other than Vivo ISAR within the last month
- Planned elective surgery in the next 6 months
- Cardiogenic shock or hemodynamically unstable patients
- Concurrent medical condition with life expectancy less than 12 months
- History of cerebrovascular accident in the last 6 months
- Vulnerable patient under guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Clinique Axium
Aix-en-Provence, France, 13100
Actively Recruiting
2
CHU CAEN
Caen, France, 14000
Not Yet Recruiting
3
Hôpital A. Schweitzer - GHCA
Colmar, France, 68003
Actively Recruiting
4
Clinique Louis Pasteur
Essey-lès-Nancy, France, 54271
Actively Recruiting
5
CH Haguenau
Haguenau, France, 67500
Actively Recruiting
6
CHU La Timone
Marseille, France, 13005
Actively Recruiting
7
Hopital Nord
Marseille, France, 13015
Not Yet Recruiting
8
HP Jacques Cartier
Massy, France, 91300
Actively Recruiting
9
Clinique Pont de Chaume
Montauban, France, 82000
Not Yet Recruiting
10
Hôpital Privé du Confluent
Nantes, France, 44277
Actively Recruiting
11
Polyclinique Les Fleurs
Ollioules, France, 83190
Actively Recruiting
12
APHP
Paris, France, 75013
Not Yet Recruiting
13
HP Claude Galien
Quincy-sous-Sénart, France, 91480
Not Yet Recruiting
14
CHU Reims
Reims, France, 51000
Actively Recruiting
15
Clinique Saint Hilaire
Rouen, France, 76000
Actively Recruiting
16
CHRU Strasbourg
Strasbourg, France, 67091
Not Yet Recruiting
17
CH de Bigorre
Tarbes, France, 65013
Actively Recruiting
18
Clinique Pasteur
Toulouse, France, 31076
Not Yet Recruiting
19
Chu Toulouse
Toulouse, France, 31400
Actively Recruiting
Research Team
B
Béatrice GODEFROY
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
0
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