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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mean in-device lumen area and mean device area

Timeframe: Through 9 months

Trial details

NCT IDNCT05464147

SponsorElixir Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03

View on ClinicalTrials.gov More Coronary Artery Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.