DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

Coronary Artery Disease Clinical Trial

— DYNAMITE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05464147
• Other study ID #: 250521
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery
• Coronary Artery Disease
• Coronary Disease
• Multi Vessel Coronary Artery Disease
• Myocardial Ischemia

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