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Completed

NCT Number: NCT06914089

Thin Versus Thicker Strut Thickness Stents in Primary Percutaneous Intervention

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

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Key information

Conditions

Primary Percutaneous Coronary Intervention

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut

Asyut, Alsabeel, 71515, Egypt

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

testing its safety and efficacy at long term follow up after primary percutaneous intervention

Primary outcomes

  1. Target vessel failure

    Time frame: 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

  2. MACE

    Time frame: 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)

  3. Late lumen Loss

    Time frame: 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 outcomes

  1. Device-oriented composite end points

    Time frame: 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)

  2. Patient-oriented composite end points

    Time frame: 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

  3. stent thrombosis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Short and Long-term Outcomes of Biodegradable Coated Stent (Biomime Versus Ultimaster) Deployed in STEMI Patients Undergoing Primary Percutaneous Intervention

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 6, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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