Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

Launched by TRANSLUMINA GMBH · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the Vivo Isar Stent System, which is a type of heart stent used to treat narrowed arteries in patients with coronary artery disease (CAD). The goal is to see how well this stent works in real-life situations and to gather information about the health outcomes of patients who receive it. Participants will be monitored for 12 months after receiving the stent to track their progress and any potential side effects.

To take part in this trial, you need to be at least 18 years old and able to give your consent to participate. You should have symptoms related to heart issues, such as chest pain or a positive test for heart problems, and you must be treated with the Vivo ISAR stent. However, if you are currently in another clinical trial, have recently undergone a different heart procedure, or have certain health conditions, you may not be eligible. If you join the study, you can expect standard care and treatment options that are typically used for patients with your condition, ensuring your safety throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥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.
• • Patient having social security number.
• • Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting
• Exclusion Criteria:
• • 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
• • Concurrent medical condition with a life expectancy of less than 12 months
• • History of cerebrovascular accident in the last 6 months.
• • Vulnerable patient under guardianship or curatorship