RecruitingNCT03588481
IRIS- DESyne X2 in the IRIS-DES Registry
Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Sponsor
Seung-Jung Park
Enrollment
1,000 participants
Start Date
Nov 28, 2018
Study Type
OBSERVATIONAL
Conditions
Summary
This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.
Eligibility
Min Age: 19 Years
Plain Language Summary
Simplified for easier understanding
This registry study tracks real-world outcomes of patients who receive the DESyne X2 drug-eluting coronary stent, which releases medication to prevent scar tissue from blocking the treated artery. As this device is used in routine clinical practice, the registry gathers long-term safety and effectiveness data.
Drug-eluting stents have significantly improved outcomes in patients with coronary artery disease by reducing re-narrowing of the artery (restenosis). Registry studies like this one provide important long-term data beyond what formal clinical trials capture.
Any adult aged 19 or older who receives the DESyne X2 stent and agrees to participate is eligible. This is an observational study with no experimental treatment involved.
You may be eligible if you:
- Are 19 years of age or older
- Have received the DESyne X2 drug-eluting coronary stent as part of your standard care
- Have signed written informed consent
You may NOT be eligible if you:
- Received a different drug-eluting stent at the same time as the DESyne X2
- Have a life expectancy of 1 year or less
- Are currently in cardiogenic shock
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DEVICEDESyne X2
Novolimus-eluting stent
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03588481
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