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

Recruiting · NCT06919562 · Observational (researchers observe without assigning treatment) · Lead sponsor: Albert Schweitzer Ziekenhuis, Netherlands

View the official record on ClinicalTrials.gov →

Heart failure

Interventions studied

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

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

Inclusion criteria

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

Exclusion criteria

Culprit lesions in the setting of acute coronary syndrome.
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.
Treatment of in-stent restenosis or stent thrombosis.
History of definite stent thrombosis.
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.
Creatinine Clearance ≤ 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.
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.
Known comorbidity associated with a life expectancy \<1 year.
Unable to understand and follow study-related instructions or unable to comply with study protocol.

Where it is running

1 location listed.

Albert Schweitzer ziekenhuis - Dordrecht, Netherlands

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →