DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

Not Applicable

Active, not recruiting

• Conditions: Multi Vessel Coronary Artery Disease; Coronary Artery Disease; Long Lesions Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery; Bifurcation of Coronary Artery
• Interventions: Device: DynamX Drug-Eluting Coronary Bioadaptor System

• Registration Number: NCT05464147
• Lead Sponsor: Elixir Medical Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-19
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-03
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DynamX Drug-Eluting Coronary Bioadaptor System	DynamX Drug-Eluting Coronary Bioadaptor System	-

Primary Outcome Measures

Name	Time	Method
Change in mean in-device lumen area and mean device area	Through 9 months	Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Italy