Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES

Study Overview
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Brief Summary
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Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

Detailed Description
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We will enroll patients with multiple coronary lesions, which, as is routine practice, will be treated with the new DES in 2 sessions (second one approximately 3-5 weeks after the first one). We will assess lesions by OFDI after the implantation and at the time of 3 months follow-up, when we will ask patients to undergo a coronary angiography. Patients will then have a follow-up contact at 1 year after initial implantation.

Official Title
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Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: TCD-10023 drug eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years old Patients is a suitable candidate for Percutaneous Coronary Intervention (PCI) Patient has multi-vessel disease with ≥2 de-novo lesions in native coronary arteries suitable for treatment with TCD-10023 DES Target lesions are suitable for OFDI examination; Patient requires staged procedure between 3-5 weeks after baseline procedure, according to investigator's judgement Target vessel reference diameter is between 2.5 - 4.0 mm (visual assessment) Patient has provided written informed consent Patient is affiliated to social security or equivalent system (France only) Exclusion Criteria: - Patient has known allergy to sirolimus, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated) Patient is not a suitable candidate for use of Dual Anti-Platelet Therapy (DAPT) because of active or recent bleedings or for use of vitamin K antagonist, like warfarin, dabigatran, rivaroxaban or acenocoumarol; Patient is presenting with ST-segment elevated MI (STEMI) at baseline procedure Patient has Killip-class > 1 at admission Patient is in cardiogenic shock Patient is a female of childbearing potential Patient has life expectancy of less then 1 year Patient is expected to undergo major surgery within 3 months Patient has Left Main disease ≥ 50% Target lesion at bifurcation requiring 2 stents technique Target lesions are severely calcified Target lesion is located within 3 mm of aorta-ostium Patient has renal failure defined as estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m² Target lesions require preparation other than balloon pre-dilatation Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study Patient is under judicial protection (France only)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCD-10023 drug eluting stent<br>All patients will be treated with the new Drug eluting stent TCD-10023 | Device: TCD-10023 drug eluting stent<br>* Implantation of new drug eluting stent in coronary artery lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OFDI assessed percent stent strut coverage |  | 3 months post procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % stent strut coverage |  | at 1 and 2 months | 
| % stented lesions with >10% uncovered struts |  | at 1, 2, 3 months | 
| % of stented lesions with >20% uncovered stent struts |  | at 1, 2, 3 months | 
| % of acquired mal-apposed stent struts |  | at 1, 2, 3 months | 
| amount (mm³) of in-stent intimal hyperplasia |  | at 1, 2, 3 months | 
| amount (mm³)of in-segment hyperplasia |  | at 1, 2, 3 months | 
| neo-intimal thickness (µm) |  | at 1, 2, 3 months | 
| in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA) |  | at 3 months | 
| In-segment late lumen loss (mm) assessed by QCA |  | at 3 months | 
| Target Lesion revascularization (TLR) |  | at 1, 3, 12 months | 
| Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR |  | at 1, 3, 12 months | 
| Target Vessel Revascularization (TVR) |  | at 1, 3, 12 months | 
| Major Cardiac Adverse Events (MACE) defined as cardiac death, Q wave and non-Q wave Myocardial Infarction (MI) , emergent coronary artery bypass surgery, or target vessel revascularization (TVR) |  | at 1, 3, 12 months | 
| Stent thrombosis |  | at 1, 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting stents, coronary artery disease, Percutaneous Coronary Intervention, Tomography, Optical Coherence