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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05464147
Other study ID # 250521
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date October 2024

Study information

Verified date September 2023
Source Elixir Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 55
Est. completion date October 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Humanitas Research Hospital Rozzano

Sponsors (2)

Lead Sponsor Collaborator
Elixir Medical Corporation Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Cardiac Death (CD) Cardiac Death (CD) 9 months, 12 months and 24 months
Secondary Myocardial Infarction (MI) Myocardial Infarction (MI) 9 months, 12 months and 24 months
Secondary Target Lesion Revascularization (TLR) Target Lesion Revascularization (TLR) 9 months, 12 months and 24 months
Secondary Stent Thrombosis (ST) Stent Thrombosis (ST) 9 months, 12 months and 24 months
Secondary Stent Cross-Sectional Area Stent Cross-Sectional Area by OCT 9 months
Secondary Minimum stent diameter Minimum stent diameter by OCT 9 months
Secondary Maximum stent diameter Maximum stent diameter by OCT 9 months
Secondary Intimal hyperplasia (IH) area Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT 9 months
Secondary Percentage of intimal hyperplasia Percentage of intimal hyperplasia (IH area divided by stent area) by OCT 9 months
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