Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

Launched by INSTITUTO NACIONAL DE CARDIOLOGIA IGNACIO CHAVEZ · Dec 3, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of heart stents, called the Orsiro stent and the Abluminus stent, to see which one works better for patients with diabetes who have heart disease. The main goal is to find out how many patients experience problems related to their stents, known as target lesion failure, within 12 months after receiving one of the stents. This study is currently recruiting participants who are at least 18 years old and have a diagnosed form of diabetes along with certain heart conditions.

To participate, you need to have diabetes and one or more blockages in your heart arteries that can be treated with a stent. However, there are some conditions that would exclude you from the study, such as having severe heart issues or allergies to specific medications. If you join the trial, you will receive one of the two stents and will be followed up for a year to see how well it works for you. This research could help improve treatment options for people with diabetes and heart disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women over 18 years of age.
• • Provide informed consent and agree to follow up as stipulated in the protocol.
• * Diabetes mellitus. Whether it is DM 1 or 2 previously diagnosed or newly diagnosed by:
• • Fasting glucose\> 126 mg / dl (for study terms, fasting will be defined as the absence of caloric intake for\> 8 hours)
• • Tolerance curve to glucose (75 grams of glucose orally) with a glycemia at 2 hours\> 200 mg / dl or,
• • HbA1C\> 6.5%.
• • Coronary artery disease including chronic coronary syndrome, silent ischemia, or non-ST-segment elevation acute coronary ischemic syndrome.
• • Presence of 1 or more de novo coronary lesions in native coronary arteries with a site of maximum stenosis\> 50% that may be amenable to stenting; without limitation in the number of lesions or vessels affected.
• Exclusion Criteria:
• • Cardiogenic shock.
• • Allergy to acetylsalicylic acid, clopidogrel, ticagrelor, prasugrel, heparin, sirolimus or contrast medium, which cannot be adequately premedicated.
• • Acute ST-segment elevation myocardial infarction candidate for primary or urgent coronary angioplasty.
• • Left main coronary artery disease.
• • In-stent restenosis.
• • Lesions in venous or arterial grafts.
• • Surgery (cardiac or non-cardiac) planned within 6 months of PCI, unless dual antiplatelet therapy can be continued in the periprocedural period.
• • Inability to provide informed consent.
• • Life expectancy \<1 year