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To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated Balloon Catheter.
Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.
Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm (Mdt Drug-Coated Balloon) | Experimental | Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Coronary Drug-Coated Balloon Catheter | Device | Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months | The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint. | At 6 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| All deaths including cardiac death.procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure |
| Target Vessel Myocardial Infarction (TVMI) |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent (balloon) and in-segment LLL | Angiographic Endpoints to be assessed at 6 months post-procedure | 6 months post-procedure |
| In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)). |
Key Inclusion Criteria
Key Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Antwerp | 2020 | Belgium | |||
| Ziekenhuis Oost-Limburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31836635 | Derived | Grosso A, Neves de Faria RI, Bojke L, Donohue C, Fraser CI, Harron KL, Oddie SJ, Gilbert R. Cost-effectiveness of strategies preventing late-onset infection in preterm infants. Arch Dis Child. 2020 May;105(5):452-457. doi: 10.1136/archdischild-2019-317640. Epub 2019 Dec 13. |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
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Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
| 30 days, 6 months and 1 year after procedure |
| Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures | 30 days, 6 months and 1 year after procedure |
| Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods. | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures | 30 days, 6 months and 1 year after procedure |
| 5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods. | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure |
| All revascularizations (TLR, TVR and non-TVR). | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure |
| Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition). | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure |
| Acute success (device, lesion and procedure success). | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure |
Angiographic Endpoints to be assessed at 6 months post-procedure
| 6 months post-procedure |
| In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)]. | Angiographic Endpoints to be assessed at 6 months post-procedure | 6 months post-procedure |
| In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD). | Angiographic Endpoints to be assessed at 6 months post-procedure | 6 months post-procedure |
| Genk |
| 3600 |
| Belgium |
| CHU Liege | Liège | 4000 | Belgium |
| IRCCS Policlinico San Donato | Milan | 20097 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 AC | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Haga Ziekenhuis locatie Leyweg | The Hague | 2545 AA | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Isala Klinieken | Zwolle | 8025 AB | Netherlands |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |