Thin Versus Thicker Strut Thickness Stents in Primary Percutaneous Intervention

NCT06914089 | Completed DMC

• 1 other identifier: Thin strut stents
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate presence of Target lesion and target vessel revascularization in in both study groups prove non inferiority of biomime stent
3. 3.To evaluate target vessel non-target lesion revasularization in both study groups prove non inferiority of biomime stent

Conditions

Primary Percutaneous Coronary Intervention

Keywords

primary percutaneous coronary intervention; ultrathin stents

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Device-oriented composite end points

  From enrollment and followed up for one year

• Patient-oriented composite end points

  From enrollment and followed up for one year

• stent thrombosis

  From enrollment and followed up for one year

Study Arms (2)

bio mime arm

ACTIVE COMPARATOR

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

Ultimaster arm

ACTIVE COMPARATOR

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

Interventions

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

Ultimaster arm; bio mime arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with ST-segment elevation myocardial infarction and diagnosed according to the last guidelines.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut

Asyut, Alsabeel, 71515, Egypt

Location

Related Publications (4)

• 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.

  PMID: 29957593 BACKGROUND

• 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.

  PMID: 29945934 BACKGROUND

• 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.

  PMID: 28498849 BACKGROUND

• 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.

  PMID: 30222120 BACKGROUND

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Short and long-term Outcomes of biodegradable coated stent (biomime versus ultimaster) deployed in STEMI patients undergoing primary percutaneous intervention

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)