| NCT ID | NCT03955731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | STEMI |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-02-15 |
| Primary Completion | 2025-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2019-02-15 with a primary completion date of 2025-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments. Compared with conventional bare-metal and drug- eluting stents, which remain permanently within the coronary anatomy, bioresorbable scaffolds (BRS) offer several potential advantages due to its resorbable properties. The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease. In particular, in comparison to polymeric bioresorbable scaffolds, no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction. A recent pilot study in eighteen patients supports this concept, which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03955731 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying STEMI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03955731 currently recruiting?
Yes, NCT03955731 is actively recruiting participants. Contact the research team at johan.bennett@uzleuven.be for enrollment information.
Where is the NCT03955731 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT03955731 clinical trial?
NCT03955731 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 100 participants.