DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (NCT05464147) | Clinical Trial Compass
UnknownNot Applicable
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
Italy55 participantsStarted 2021-10-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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).
What they're measuring
1
Change in mean in-device lumen area and mean device area