coronary artery disease coronary stenosis
Conditions
Interventions
A PTCA will be performed with the Medtronic drug-coated ballon to evaluate the
safety and efficacy.
Drug coated ballon catether
Pre-market study
Procedure is standard of care
Safety and efficacy
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Subject with documented stable or unstable angina, and/or clinical evidence of ischemia - Subject is an acceptable candidate for treatment with a Drug-Coated Coranary Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer*s Instructions for Use and the Declaration of Helsinki. - Successful pre-dilatation of the (entire) target lesion(s) that will be treated with the investigational device. Success being documented by angiographic visual estimate of Grade B) flow-limiting dissection. - Subject has a life expectancy >1 year in the Investigator*s opinion. - Subject is willing and able to cooperate with study procedures and required follow up evaluations. Angiographic Inclusion: - The patient requires treatment of either: A. At least a single lesion* amenable to treatment with the Medtronic Coronary Drug-Coated Balloon (* if two lesions can be treated by one Drug-Coated Balloon covering both lesions, it will be considered as a single target lesion). OR B. A maximum of four lesions in a maximum of 3 vessels. In case 3 vessels require to be treated, at least one should receive a non-DCB treatment, i.e. treatment with a Drug Eluting Stent (DES); this will be called a non-target lesion. Lesions (max. 3) treated with the DCB are considered target lesions. Note: For subjects with a planned treatment of two to four lesions, the first lesion must be treated successfully and the subject must be clinically stable before treatment of the following one to three lesions are attempted. The lesion(s) in each vessel that is (/are) planned to be treated with the DES should be treated first. - Target lesion(s) must be * 25 mm in length. - Target lesion(s) must have a stenosis of * 50% and
Exclusion criteria
Exclusion criteria: - Known hypersensitivity or contraindication to aspirin; heparin; bivalirudin; clopidogrel; prasugrel; ticagelor and structurally related compounds; or a sensitivity to contrast media, which cannot be adequately pre-medicated. - History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative. - Platelet count 700,000 cells/mm³ (i.e. 700 x 109/L), or a white blood cell (WBC) count 2.5 mg/dl (i.e. 221 *mol/L) within 7 days prior to index procedure - Evidence of an Acute Myocardial Infarction within the previous 72 hours of the study procedure. - Planned treatment of the left main coronary artery, internal mammary artery, aorto-ostial, and sapheneous vein grafts with the investigational device. - Planned treatment of more than one lesion in one target vessel, or more than two lesions in two target vessels. - Planned treatment involves a bifurcation. - Previous percutaneous coronary intervention (PCI) of the target vessels(s) - within 3 months prior to the procedure for In-Stent Restenosis; - within 9 months prior to the procedure for de novo lesions. - Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 6 months post-procedure. - During the index procedure, the target lesion(s) require(s) treatment with a cutting/scoring balloon, atherectomy, laser, or thrombectomy procedure. - History of a stroke or transient ischemic attack (TIA) within the prior 6 months (any prior stroke or TIA, if prasugrel is used). - Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months. - History of bleeding diathesis or coagulopathy or will refuse blood transfusions. - Any previous treatment of the target vessel for restenosis, including brachytherapy. - Pregnant or breast-feeding woman. - Documented left ventricular ejection fraction (LVEF) 90º to reach the target lesion). - Target lesion(s) has/have any of the following characteristics: a. Lesion location is aorto-ostial, an unprotected left main lesion, or within 5mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) b. Involves a side branch >2.0mm in diameter c. Is at a >45º bend in the vessel d. Is severely calcified - Unprotected left main coronary artery disease is present (an obstruction greater than 50% in the left main coronary artery). - Lesion that is planned to be treated is longer than 25 mm in length or RVD is smaller than 2 mm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent (in balloon) Late lumen loss (LLL) at 6 months post-procedure as measured by quantitative coronary angiography (QCA). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All deaths including cardiac death. 2. Target Vessel Myocardial infarction (TVMI). 3. Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods. 4. Target vessel failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods. 5. Target lesion failure (TLF) defined by a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. 6. All revascularizations (target lesion revascularization (TLR), target vessel revascularization (TVR) and non-TVR). 7. Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium (ARC) definition). 8. Acute success (device, lesion and procedure success). Angiographic Endpoints: Angiographic parameters to be assessed at 6 months post-procedure including: 1. In-stent (balloon) and in-segment LLL 2. In-stent (balloon) and in-segment percent diameter stenosis (%DS). 3. In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as *50% diameter stenosis (DS)]. 4. In-stent (balloon) and in-segment Minimal luminal diameter (MLD). | — |
Countries
The Netherlands
Outcome results
None listed