DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

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

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.

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).