Bifurcation of Coronary Artery, Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Long Lesions Coronary Artery Disease, Multi Vessel Coronary Artery Disease
Conditions
Brief summary
The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.
Interventions
DEVICEDynamX Drug-Eluting Coronary Bioadaptor System
DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion
Sponsors
Elixir Medical Corporation
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
All imaging analyses will be performed at an independent core laboratory (Cardiovascular Department, San Giovanni Addolorata Hospital, Rome, Italy) by experienced operators blinded to procedural data and clinical outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Presence of complex coronary lesions defined as follows: * long lesions (\>28 mm); * CTO, a total occlusion of duration more than 3-months; * Lesions involving a bifurcation, defined as a division with a side branch large enough to be stented (i.e. \>2.25 mm); * Patients requiring 4 or more stents * Reference vessel diameter: \>2.25 mm to \<4.0 mm
Exclusion criteria
* Age under 18 years old; * Significant co-morbidity precluding clinical follow-up; * A positive pregnancy test in women with child-bearing potential; * Contra-indication to dual anti-platelet therapy; * Thrombocytopenia \<100,000/uL; * Major surgery planned which will lead to discontinuation of antiplatelet therapy; * In-stent restenosis; * Treatment of saphenous vein graft; * CTO with long sub-intimal tracking (\> 20 mm).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean in-device lumen area and mean device area | Through 9 months | Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Event (MACE) | 9 months, 12 months and 24 months | Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction \[MI\], and target lesion revascularization \[TLR\]) |
| Cardiac Death (CD) | 9 months, 12 months and 24 months | Cardiac Death (CD) |
| Myocardial Infarction (MI) | 9 months, 12 months and 24 months | Myocardial Infarction (MI) |
| Target Lesion Revascularization (TLR) | 9 months, 12 months and 24 months | Target Lesion Revascularization (TLR) |
| Stent Thrombosis (ST) | 9 months, 12 months and 24 months | Stent Thrombosis (ST) |
| Stent Cross-Sectional Area | 9 months | Stent Cross-Sectional Area by OCT |
| Minimum stent diameter | 9 months | Minimum stent diameter by OCT |
| Maximum stent diameter | 9 months | Maximum stent diameter by OCT |
| Intimal hyperplasia (IH) area | 9 months | Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT |
| Percentage of intimal hyperplasia | 9 months | Percentage of intimal hyperplasia (IH area divided by stent area) by OCT |
Countries
Italy
Outcome results
None listed