DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

Study Overview
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Brief Summary
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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.

Official Title
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DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE Study)

Conditions
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Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery, Multi Vessel Coronary Artery Disease, Long Lesions Coronary Artery Disease

Intervention / Treatment
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* Device: DynamX Drug-Eluting Coronary Bioadaptor System


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DynamX Drug-Eluting Coronary Bioadaptor System<br> | Device: DynamX Drug-Eluting Coronary Bioadaptor System<br>* DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean in-device lumen area and mean device area | Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT) | Through 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Event (MACE) | Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) | 9 months, 12 months and 24 months | 
| Cardiac Death (CD) | Cardiac Death (CD) | 9 months, 12 months and 24 months | 
| Myocardial Infarction (MI) | Myocardial Infarction (MI) | 9 months, 12 months and 24 months | 
| Target Lesion Revascularization (TLR) | Target Lesion Revascularization (TLR) | 9 months, 12 months and 24 months | 
| Stent Thrombosis (ST) | Stent Thrombosis (ST) | 9 months, 12 months and 24 months | 
| Stent Cross-Sectional Area | Stent Cross-Sectional Area by OCT | 9 months | 
| Minimum stent diameter | Minimum stent diameter by OCT | 9 months | 
| Maximum stent diameter | Maximum stent diameter by OCT | 9 months | 
| Intimal hyperplasia (IH) area | Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT | 9 months | 
| Percentage of intimal hyperplasia | Percentage of intimal hyperplasia (IH area divided by stent area) by OCT | 9 months |