Primary Percutaneous Coronary Intervention
Conditions
Keywords
primary percutaneous coronary intervention, ultrathin stents
Brief summary
1. To evaluate clinical safety of the device in terms of Deaths, any stroke and Myocardial Infarction up to 1 year in both study groups to prove non inferiority of biomime stent 2. To evaluate presence of Target lesion and target vessel revascularization in in both study groups prove non inferiority of biomime stent 3. To evaluate target vessel non-target lesion revasularization in both study groups prove non inferiority of biomime stent
Detailed description
• Drug-eluting stents (DES) represent a key advance in percutaneous coronary interventions (PCI) owing to their ability to inhibit neointimal proliferation, which lowers the need for repeat revascularisation However, older-generation DES have been shown to increase the risk of late restenosis and stent thrombosis. Efforts to reduce these risks include improvements in stent platforms, polymer carriers, and drug selection. Thinner struts reduce vessel wall injury, decrease inflammation and promote fast endothelialisation.The second-generation thin-strut DES have been shown to reduce the risk of restenosis, stent thrombosis and myocardial infarction (MI) or possibly death when compared with older-generation DES or bare metal stents. Moreover, the newer generation of biodegradable polymer stents has the potential to reduce the inflammatory reaction of the arterial wall and minimise the risk of late restenosis and thrombus formation More recently, ultra-thin (\<70 μm) DES have been shown to improve outcomes further compared with second-generation DES.The BioMime™ (Meril Life Sciences Pvt. Ltd., Vapi, India) is an ultra-thin sirolimus-eluting coronary stent (SES) with an established preliminary safety and efficacy record in the previous meriT-1, meriT-2, meriT-3 and meriT-4 trials in treating single de novo and complex lesions.The BioMime is an ultra-thin strut (65 µm) SES that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges which lead to Lesser Edge Dissections during expansion and Adequate Side Branch Access, coated with biocompatible and bioabsorbable polymers, PLLA (poly-L-lactic acid) and PLGA (poly-lactic-co-glycolic acid) for Faster Healing
Interventions
DEVICEThe BioMime is an ultra-thin strut (65 µm) SES that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges
testing its safety and efficacy at long term follow up after primary percutaneous intervention
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
•All patients with ST-segment elevation myocardial infarction and diagnosed according to the last guidelines.
Exclusion criteria
* Left ventricular ejection fraction ≤30%. * Killip class III or IV at presentation. * Extreme vessel tortuosity or lesion angulation (˂45˚). * Severe calcification proximal to or within the target lesion. * Bifurcation lesions with side branch diameter \>2 mm. * Mechanical complication of STEMI. * Severe comorbidity such as malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel failure | From enrollment and followed up for one year | Target vessel failure (TVF): defined as cardiac death that cannot be clearly attributed to a vessel other than the target vessel, target vessel MI, and clinically driven target vessel revascularization |
| MACE | From enrollment and followed up for one year | Major adverse cardiac events (MACE) as a composite of cardiac death, any MI and clinically driven target vessel revascularization (CD-TVR) |
| Late lumen Loss | From enrollment and followed up for one year | Late lumen loss: the difference between the minimal luminal diameter (MLD) after stent implantation and after at least 9 months post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented composite end points | From enrollment and followed up for one year | Device-oriented composite end points (DOCE): Defined as Cardiovascular death, MI (not clearly attributable to a non-target vessel) and TLR (clinically driven) |
| Patient-oriented composite end points | From enrollment and followed up for one year | Patient-oriented composite end points (POCE): Defined as all-cause mortality, any stroke, Any MI (includes non-target vessel territory) and Any revascularization |
| stent thrombosis | From enrollment and followed up for one year | Definite stent thrombosis: The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent or in a side branch originating from the stented segment and the presence of at least one of the following criteria: A) Acute onset of ischemic symptoms at rest B) New electrocardiographic changes suggestive of acute ischemia C) Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction). Probable stent thrombosis Regardless of the time after the index procedure, any myocardial infarction that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent/scaffold thrombosis and in the absence of any other obvious cause. Timing of ST (duration after stent implantation) Acute: 0-24 h & Sub-acute \>24 h-30 d & Late \>30 d-1 y & Very late \>1 y |
Countries
Egypt
Outcome results
None listed