Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Ischemic Heart Disease, Stenotic Coronary Lesion
Conditions
Keywords
Long Lesion, In-stent Late Lumen Loss (LLL), Major Adverse Cardiac Events (MACE), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST)
Brief summary
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
Interventions
DEVICEResolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)
The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity 34/38 mm stent * The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length \>27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent Key
Exclusion criteria
* STEMI within 24 hours * Left main disease * Bifurcation disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss, in stent | 9 months (m) | Late lumen loss measured by quantitative coronary angiography (QCA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | All death |
| Myocardial infarction | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | All MI, and Target Vessel Myocardial Infarction (TVMI) |
| All revascularizations | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR |
| Target Vessel Failure (TVF) | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | TVF |
| Target Lesion Failure (TLF) | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | TLF |
| Stent Thrombosis (ST) | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | ST |
| Major Adverse Cardiac Events (MACE) | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods |
| Lesion Success | At the end of index procedure, an expected average of 3 days | The attainment of \<50% residual stenosis of the target lesion using any percutaneous method. The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory. |
| Procedure Success | Duration of hospital stay, an expected average of 5 days | The attainment of \<50% residual stenosis of the target lesion and no in-hospital MACE. The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. |
| In-stent and in-segment percent diameter stenosis (%DS) | 9 months | In-stent and in-segment percent diameter stenosis (%DS) |
| In-stent and in-segment binary restenosis rate | 9 months | In-stent and in-segment binary restenosis rate |
| In-stent and in-segment minimal luminal diameter (MLD) | 9 months | In-stent and in-segment minimal luminal diameter (MLD) |
| In-segment late luminal loss | 9 months | In-segment late luminal loss |
| Device Success | At the end of index procedure, an expected average of 3 days | The attainment of \<50% residual stenosis of the target lesion using only the assigned device. The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory. |
Countries
China
Outcome results
None listed