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

Elixir Medical

Status

Active, not recruiting

Conditions

Coronary Artery Disease

Long Lesions Coronary Artery Disease

Multi Vessel Coronary Artery Disease

Bifurcation of Coronary Artery

Chronic Total Occlusion of Coronary Artery

Treatments

Device: DynamX Drug-Eluting Coronary Bioadaptor System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05464147

250521

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).