Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
ConditionArtery Coronary Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTranslumina GmbH
About this trial
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.
Eligibility criteria
Qualifiers
≥18 years old
Ability to provide signed informed consent form.
Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age)
Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis.
Disqualifiers
Concurrent participation in another clinical trial.
Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR.
Planned elective surgery in next 6 months
Cardiogenic shock/ hemodynamically unstable patients
Trial design
Treatments tested in this trial
- Percutaneous Coronary Intervention
Treatment groups
No treatment groups listed
Sponsors and collaborators
Translumina GmbH
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov