Coronary Artery Disease, In-stent Restenosis, Ischemic Heart Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMedtronic Coronary Drug-Coated Balloon Catheter
Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Subject with documented stable or unstable angina, and/or clinical evidence of ischemia * Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki. Key
Exclusion criteria
* Acute Myocardial Infarction within the previous 72 hours * Planned treatment involves a bifurcation * Three vessel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months | At 6 months follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures |
| 5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods. | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure |
| All revascularizations (TLR, TVR and non-TVR). | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 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). | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure |
| Acute success (device, lesion and procedure success). | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure |
| All deaths including cardiac death.procedure | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure |
| Target Vessel Myocardial Infarction (TVMI) | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 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. | 30 days, 6 months and 1 year after procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures |
Other
| Measure | Time frame | Description |
|---|---|---|
| In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)). | 6 months post-procedure | Angiographic Endpoints to be assessed at 6 months post-procedure |
| In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)]. | 6 months post-procedure | Angiographic Endpoints to be assessed at 6 months post-procedure |
| In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD). | 6 months post-procedure | Angiographic Endpoints to be assessed at 6 months post-procedure |
| In-stent (balloon) and in-segment LLL | 6 months post-procedure | Angiographic Endpoints to be assessed at 6 months post-procedure |
Countries
Belgium, Italy, Netherlands
Outcome results
None listed