NCT05464147Completed
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE Study)
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 13 Jul 2022
- Start date
- 19 Oct 2021
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Elixir Medical Corporation
- Diseases
- Coronary artery disease
- NCT number
- NCT05464147
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 19 Oct 2021 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery planned which will lead to discontinuation of antiplatelet therapy;
Lab values
- Contra-indication to dual anti-platelet therapy;
Age
- Age under 18 years old;
Other
- Significant co-morbidity precluding clinical follow-up;
- A positive pregnancy test in women with child-bearing potential;
- Thrombocytopenia \<100,000/uL;
- In-stent restenosis;
- Treatment of saphenous vein graft;
- CTO with long sub-intimal tracking (\> 20 mm).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.