Humanitas Research Hospital
Rozzano, Italy
NCT Number: NCT05464147
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rozzano, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Presence of complex coronary lesions defined as follows:
Exclusion criteria
DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion
Time frame: Through 9 months
Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT)
Time frame: 9 months, 12 months and 24 months
Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR])
Time frame: 9 months, 12 months and 24 months
Cardiac Death (CD)
Time frame: 9 months, 12 months and 24 months
Myocardial Infarction (MI)
Time frame: 9 months, 12 months and 24 months
Target Lesion Revascularization (TLR)
Time frame: 9 months, 12 months and 24 months
Stent Thrombosis (ST)
Time frame: 9 months
Stent Cross-Sectional Area by OCT
Time frame: 9 months
Minimum stent diameter by OCT
Time frame: 9 months
Maximum stent diameter by OCT
Time frame: 9 months
Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT
Time frame: 9 months
Percentage of intimal hyperplasia (IH area divided by stent area) by OCT
Elixir Medical Corporation
Industry
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE Study)
Acronym: DYNAMITE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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