Thin Versus Thicker Strut Thickness Stents in Primary Percutaneous Intervention

Not Applicable

Completed

• Conditions: Primary Percutaneous Coronary Intervention

• Registration Number: NCT06914089
• Lead Sponsor: Assiut University

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

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-09-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assiut; 🇪🇬 Assiut, Alsabeel, Egypt