NCT06919562 OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure
| NCT ID | NCT06919562 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert Schweitzer Ziekenhuis, Netherlands |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 117 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2030-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 117 participants in total. It began in 2025-11-04 with a primary completion date of 2030-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06919562 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919562 currently recruiting?
Yes, NCT06919562 is actively recruiting participants. Contact the research team at j.m.cheng@asz.nl for enrollment information.
Where is the NCT06919562 trial being conducted?
This trial is being conducted at Dordrecht, Netherlands.
Who is sponsoring the NCT06919562 clinical trial?
NCT06919562 is sponsored by Albert Schweitzer Ziekenhuis, Netherlands. The trial plans to enroll 117 participants.