OCT Guided Magmaris RMS in STEMI

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · May 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special type of stent called the Magmaris, which is made from magnesium and is designed to dissolve over time. This study focuses on patients who have experienced a specific kind of heart attack known as ST-elevation myocardial infarction (STEMI). The trial aims to see if this dissolvable stent can provide better outcomes than traditional stents, particularly since there have not been any reports of serious complications like blood clots with this type of stent in previous studies.

To participate in this trial, patients should be between 18 and 70 years old and must have had symptoms of a STEMI for less than 24 hours or still be experiencing symptoms. Some individuals, such as those with certain medical conditions or those who have had previous stents placed, may not be eligible. Participants will receive the Magmaris stent and will be monitored closely over time to assess their recovery and the effectiveness of the treatment. This study is currently recruiting participants, so if you or someone you know might be interested, it could be a great opportunity to contribute to important heart health research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset \<24 hours or with ongoing symptoms.
• • 2. Signed patient informed consent.
• Exclusion Criteria:
• • 1. Age \< 18 or \> 70 years.
• • 2. Pregnancy or breastfeeding.
• • 3. Cardiogenic shock.
• • 4. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
• • 5. Infarct-artery reference diameter \< 2.7 or \> 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter \< 2.7 or \> 3.7 mm
• • 6. Non-optimal vessel preparation after predilatation: residual stenosis \>30%.
• • 7. Culprit lesion length \> 21 mm.
• • 8. Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
• • 9. Culprit lesion involving a saphenous vein graft.
• • 10. Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
• • 11. Ostial right coronary artery
• • 12. Severe calcification or tortuosity of the infarct-related artery.
• • 13. Absolute contraindication to a 12 months dual antiplatelet therapy.
• • 14. Life expectancy \< 3 years.
• • 15. Patients taking oral anticoagulant therapy