Orsiro Mission Stent System for Coronary Artery Disease
This study is testing the safety and effectiveness of a medical device called the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System. This stent is used to treat blockages (atherosclerotic lesions) in the heart's arteries (coronary arteries). The stent is a small mesh tube that helps keep the artery open, and it releases a medicine called sirolimus. Researchers want to see how well the stent works and if it causes any problems over time. You may be able to join if you are at least 18 years old and have coronary artery disease with specific lesion lengths and vessel sizes. The main goal is to measure how many people experience a problem with the treated artery (Target Lesion Failure) within 12 months.
- Study design
- This is an interventional study planning to enroll 150 participants. The study type and phase are not specified.
- What's involved
- If you enroll in the United States, you will have follow-up visits at 1, 6, 12 months, and 2 years after the procedure. If you enroll outside the United States, you will have additional visits at 3 and 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in the United States will be followed for 2 years, and those outside the United States will be followed for 5 years after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
At a glance
Conditions
Where it's being run
23 sites across 20 statesWho to contact
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What this trial measures
- Target Lesion Failure (TLF) rate at 12 months post-index procedure12 months
The primary endpoint will be target lesion failure (TLF) rate at 12 months post-index procedure. TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).