NCT06919562Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 117 (estimated)
- First submitted
- 2 Apr 2025
- Start date
- 4 Nov 2025
- Primary completion date
- Aug 2030
- Lead sponsor
- Albert Schweitzer Ziekenhuis, Netherlands
- NCT number
- NCT06919562
What you commit to
- Study type: Observational
- Planned participants: 117
- From 4 Nov 2025 to the primary completion date, Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.
- Planned non-deferrable major surgery after PCI.
Other illness
- Culprit lesions in the setting of acute coronary syndrome.
- Treatment of in-stent restenosis or stent thrombosis.
- History of definite stent thrombosis.
Lab values
- Creatinine Clearance ≤ 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.
Other
- Lesions with severe calcification.
- Lesions in a coronary artery with severe tortuosity.
- Left main coronary artery lesions.
- Bifurcation lesions.
- Ostial lesions.
- 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.
- Lesions in coronary artery bypass grafts.
- Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation.
- Known comorbidity associated with a life expectancy \<1 year.
- Unable to understand and follow study-related instructions or unable to comply with study protocol.
Who the study is looking for
- 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.
- Subject must be at least 18 years of age
- Written consent to participate in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.