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New treatment option for STEMI
Official title OCT Guided Magmaris RMS in STEMI
ClinicalTrials.gov ID: NCT03955731
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset \<24 hours or with ongoing symptoms.
- Signed patient informed consent.
You likely can't join if
- Age \ 70 years.
- Pregnancy or breastfeeding.
- Cardiogenic shock.
- Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent...
- Infarct-artery reference diameter \ 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference...
- Non-optimal vessel preparation after predilatation: residual stenosis \>30%.
See the full eligibility criteria
- Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset \<24 hours or with ongoing symptoms.
- Signed patient informed consent.
- Age \ 70 years.
- Pregnancy or breastfeeding.
- Cardiogenic shock.
- 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.
- Infarct-artery reference diameter \ 4.0 mm (within the segment of the culprit lesion) by visual estimation, and OCT infarct-artery distal reference mean lumen diameter \ 3.7 mm
- Non-optimal vessel preparation after predilatation: residual stenosis \>30%.
- Culprit lesion length \> 21 mm.
- Culprit lesion located within a previously stented segment (stent thrombosis or in-stent restenosis).
- Culprit lesion involving a saphenous vein graft.
- Culprit lesion involving a bifurcation with an intended two-stent implantation strategy.
- Ostial right coronary artery
- Severe calcification or tortuosity of the infarct-related artery.
- Absolute contraindication to a 12 months dual antiplatelet therapy.
- Life expectancy \< 3 years.
- Patients taking oral anticoagulant therapy
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.