OPtimal stEnt Deployment stRategy oF Contemporary sTents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2030-08-31

Brief Summary

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Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.

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Detailed Description

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Conditions

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Coronary Arterial Disease (CAD) Percutaneous Coronary Intervention (PCI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging

Percutaneous coronary intervention (PCI) with implantation of the MeRes100 thin-strut BRS with protocolized PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Stable coronary artery disease with one or more significant epicardial stenosis in native coronary arteries suitable for OCT or IVUS-guided PCI with BRS implantation.
2. Subject must be at least 18 years of age
3. Written consent to participate in the study

Exclusion Criteria

1. Culprit lesions in the setting of acute coronary syndrome.
2. Lesions with severe calcification.
3. Lesions in a coronary artery with severe tortuosity.
4. Left main coronary artery lesions.
5. Bifurcation lesions.
6. Ostial lesions.
7. Lesions with a difference in proximal and distal reference diameter of \>0.5 mm by visual judgement of the coronary angiogram by the treating operator.
8. Treatment of in-stent restenosis or stent thrombosis.
9. History of definite stent thrombosis.
10. Lesions in coronary artery bypass grafts.
11. Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation.
12. Creatinine Clearance ≤ 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.
13. Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.
14. Planned non-deferrable major surgery after PCI.
15. Known comorbidity associated with a life expectancy \<1 year.
16. Unable to understand and follow study-related instructions or unable to comply with study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No