Thin Versus Thicker Strut Thickness Stents in Primary Percutaneous Intervention

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

Study Overview

• Status: Completed
• Conditions: Primary Percutaneous Coronary Intervention
• Intervention / Treatment: Device: 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

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 Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alsabeel
    • Assiut, Alsabeel, Egypt, 71515
      • Assiut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bio mime arm; ultrathin stent arm	Device: 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; testing its safety and efficacy at long term follow up after primary percutaneous intervention
Active Comparator: Ultimaster arm; The Ultimaster® (Terumo CorporationTokyo, Japan) consists of the Kaname stent platform, abluminally coated with poly D,L-lactic acid-polycaprolactone (PDLLA-PCL) as a carrier of the immunosuppressant drug sirolimus (3.9 μg/mm stent length). The purpose of the gradient coating is to reduce potential cracking and delamination of the polymer. The drug release profile allows an initial stronger release immediately following stent implantation. Then the drug is released continuously until the polymer bioabsorption is completed within three to four months. For a stent size of 3.0×15 mm, the median maximum concentration (Cmax) was 36.8 pg/mL (range between 22.9 and 41.5 pg/mL), according to the previously published detailed information on the pharmacokinetic profile	Device: 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; testing its safety and efficacy at long term follow up after primary percutaneous intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel failure	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	From enrollment and followed up for one year
MACE	Major adverse cardiac events (MACE) as a composite of cardiac death, any MI and clinically driven target vessel revascularization (CD-TVR)	From enrollment and followed up for one year
Late lumen Loss	Late lumen loss: the difference between the minimal luminal diameter (MLD) after stent implantation and after at least 9 months post procedure	From enrollment and followed up for one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented composite end points	Device-oriented composite end points (DOCE): Defined as Cardiovascular death, MI (not clearly attributable to a non-target vessel) and TLR (clinically driven)	From enrollment and followed up for one year
Patient-oriented composite end points	Patient-oriented composite end points (POCE): Defined as all-cause mortality, any stroke, Any MI (includes non-target vessel territory) and Any revascularization	From enrollment and followed up for one year
stent thrombosis	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	From enrollment and followed up for one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Magdy algowhary, MD, Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt.; Principal Investigator: Salwa R Demitry, MD, Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: primary percutaneous coronary intervention; ultrathin stents
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Cobalt; Chromium
• Other Study ID Numbers: Thin strut stents

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No