DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

Elixir Medical Corporation55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

DynamX Drug-Eluting Coronary Bioadaptor SystemDEVICE

DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Humanitas Research Hospital

Rozzano, Italy

Outcomes

Primary Outcomes

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)

Time frame: Through 9 months

Secondary Outcomes

Major Adverse Cardiac Event (MACE)

Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction \[MI\], and target lesion revascularization \[TLR\])