Clinical trial NCT06914089: Thin Versus Thicker Strut Thickness Stents in Primary Percutaneous Intervention
Official title: Short and Long-term Outcomes of Biodegradable Coated Stent (Biomime Versus Ultimaster) Deployed in STEMI Patients Undergoing Primary Percutaneous Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Percutaneous Coronary Intervention
Keywords: primary percutaneous coronary intervention
ultrathin stents
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Target vessel failure
timeFrame: From enrollment and followed up for one year
measure: MACE
timeFrame: From enrollment and followed up for one year
measure: Late lumen Loss
timeFrame: From enrollment and followed up for one year
Secondary outcomes:
measure: Device-oriented composite end points
timeFrame: From enrollment and followed up for one year
measure: Patient-oriented composite end points
timeFrame: From enrollment and followed up for one year
measure: stent thrombosis
timeFrame: From enrollment and followed up for one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut
state: Alsabeel
Study officials:
affiliation: Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt.
name: Magdy algowhary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt.
name: Salwa R Demitry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valdes-Chavarri M, Kedev S, Neskovic AN, Moris de la Tassa C, Zivkovic M, Trillo Nouche R, Vazquez Gonzalez N, Bartorelli AL, Antoniucci D, Tamburino C, Colombo A, Abizaid AA, McFadden E, Garcia-Garcia HM, Milasinovic D, Stankovic G. Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study. EuroIntervention. 2019 Apr 5;14(18):e1836-e1842. doi: 10.4244/EIJ-D-17-01087.
citation: Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease. Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456.
citation: Poder TG, Erraji J, Coulibaly LP, Koffi K. Percutaneous coronary intervention with second-generation drug-eluting stent versus bare-metal stent: Systematic review and cost-benefit analysis. PLoS One. 2017 May 12;12(5):e0177476. doi: 10.1371/journal.pone.0177476. eCollection 2017.
citation: Abizaid A, Kedev S, Kedhi E, Talwar S, Erglis A, Hlinomaz O, Masotti M, Fath-Ordoubadi F, Lemos PA, Milewski K, Botelho R, Costa R, Bangalore S. Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial. EuroIntervention. 2018 Dec 7;14(11):e1207-e1214. doi: 10.4244/EIJ-D-18-00762.