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| ID | Type | Description | Link |
|---|---|---|---|
| NL-009177 | Other Identifier | CCMO |
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| Name | Class |
|---|---|
| Meril Life Sciences Pvt. Ltd. | INDUSTRY |
| Angiocare BV, Netherlands | UNKNOWN |
| Salveo Medical BV, Netherlands | UNKNOWN |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging | Procedure | Percutaneous coronary intervention (PCI) with implantation of the MeRes100 thin-strut BRS with protocolized PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Percentage of technical success, defined as successful implantation of the BRS in the obstructive coronary lesion. | End of procedure |
| Angiographic success | Percentage of angiographic success, defined as <10% residual stenosis and TIMI 3 flow. | End of procedure |
| Treatment protocol adherence | Percentage of treatment protocol adherence, defined as full completion of all PSP and intracoronary imaging steps during implantation procedure. | End of procedure |
| Optimal scaffold result | Percentage of optimal scaffold result on intracoronary imaging, defined as no major edge dissection, no major malexpansion and scaffold expansion >90%. | End of procedure |
| Additional optimization steps | Percentage of additional optimization steps (including additional postdilatation, additional BRS implantation, bailout metallic DES implantation, additional intracoronary imaging) to achieve optimal scaffold result. | End of procedure |
| Target Lesion Failure | Estimate of target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization | 1-year and 3-year post-procedure |
| Scaffold thrombosis |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal scaffold area | Minimal scaffold area assessed with the final OCT or IVUS measurement | End of procedure |
| Scaffold malapposition | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with obstructive stable coronary artery disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin M. Cheng, MD, PhD | Contact | +31786541492 | j.m.cheng@asz.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Schweitzer ziekenhuis | Recruiting | Dordrecht | Netherlands |
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Estimate of scaffold thrombosis
| 1-year and 3-year post-procedure |
| End of procedure |
| Scaffold expansion | 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. | End of procedure |
| Edge dissection | Presence of edge dissection assessed with the final OCT or IVUS measurement. | End of procedure |
| Intra-scaffold plaque protrusion and thrombus | 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. | End of procedure |
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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