Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Conditions
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.
Interventions
PROCEDUREPercutaneous 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.
Sponsors
Albert Schweitzer Ziekenhuis, Netherlands
Meril Life Sciences Pvt. Ltd.
Angiocare BV, Netherlands
Salveo Medical BV, Netherlands
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Additional optimization steps | End of procedure | Percentage of additional optimization steps (including additional postdilatation, additional BRS implantation, bailout metallic DES implantation, additional intracoronary imaging) to achieve optimal scaffold result. |
| Target Lesion Failure | 1-year and 3-year post-procedure | Estimate of target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization |
| Scaffold thrombosis | 1-year and 3-year post-procedure | Estimate of scaffold thrombosis |
| Optimal scaffold result | End of procedure | Percentage of optimal scaffold result on intracoronary imaging, defined as no major edge dissection, no major malexpansion and scaffold expansion \>90%. |
| Technical success | End of procedure | Percentage of technical success, defined as successful implantation of the BRS in the obstructive coronary lesion. |
| Angiographic success | End of procedure | Percentage of angiographic success, defined as \<10% residual stenosis and TIMI 3 flow. |
| Treatment protocol adherence | End of procedure | Percentage of treatment protocol adherence, defined as full completion of all PSP and intracoronary imaging steps during implantation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-scaffold plaque protrusion and thrombus | End of procedure | Intra-scaffold plaque protrusion and thrombus, defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut, assessed with the final OCT or IVUS measurement. |
| Minimal scaffold area | End of procedure | Minimal scaffold area assessed with the final OCT or IVUS measurement |
| Scaffold malapposition | End of procedure | Scaffold malapposition as percentage, defined as frequency of incompletely apposed struts (i.e. struts clearly separated from the vessel wall without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch) assessed with the final OCT or IVUS measurement. |
| Scaffold expansion | End of procedure | Scaffold expansion as percentage, defined as scaffold area divided by the average of proximal and distal reference lumen areas, assessed with the final OCT or IVUS measurement. |
| Edge dissection | End of procedure | Presence of edge dissection assessed with the final OCT or IVUS measurement. |
Countries
Netherlands
Contacts
CONTACTJin M. Cheng, MD, PhD
Outcome results
None listed