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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCD-10023 drug eluting stent | Experimental | All patients will be treated with the new Drug eluting stent TCD-10023 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCD-10023 drug eluting stent | Device | Implantation of new drug eluting stent in coronary artery lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| OFDI assessed percent stent strut coverage | 3 months post procedure. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter Smits, MD | Maasstad hospital, Rotterdam, the Netherlands | Study Chair |
| Bernard Chevalier, MD | Cardiovascular Institute Paris Sud, Massy, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute Paris Sud (ICPS) | Massy | 91300 | France | |||
| CHU Rangueil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29246909 | Derived | Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| Toulouse |
| 31059 |
| France |
| LMU | München | 81377 | Germany |
| MCL | Leeuwarden | 8934 ad | Netherlands |
| Erasmus | Rotterdam | 3015 CE | Netherlands |
| Maasstadziekenhuis | Rotterdam | Netherlands |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |