Coronary Artery DiseaseDYNAMITENCT05464147
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
A study testing DynamX Drug-Eluting Coronary Bioadaptor System in people with Coronary Artery Disease and Chronic Total Occlusion of Coronary Artery, run by Elixir Medical Corporation at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery
- What is being tested?
- DynamX Drug-Eluting Coronary Bioadaptor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2021to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- In-stent restenosis;
- Treatment of saphenous vein graft;
- CTO with long sub-intimal tracking (> 20 mm).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery, Multi Vessel Coronary Artery Disease, Long Lesions Coronary Artery Disease
- Being tested
- DynamX Drug-Eluting Coronary Bioadaptor System
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynamX Drug-Eluting Coronary Bioadaptor SystemDevice
DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion
| Study group | Role | What they receive |
|---|---|---|
| DynamX Drug-Eluting Coronary Bioadaptor System | Experimental | Not described Receives: Device: DynamX Drug-Eluting Coronary Bioadaptor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean in-device lumen area and mean device area
Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT)
Measured: Through 9 months
Secondary outcomes (10)
Major Adverse Cardiac Event (MACE)
Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR])
Measured: 9 months, 12 months and 24 months
Cardiac Death (CD)
Cardiac Death (CD)
Measured: 9 months, 12 months and 24 months
Myocardial Infarction (MI)
Myocardial Infarction (MI)
Measured: 9 months, 12 months and 24 months
Target Lesion Revascularization (TLR)
Target Lesion Revascularization (TLR)
Measured: 9 months, 12 months and 24 months
Stent Thrombosis (ST)
Stent Thrombosis (ST)
Measured: 9 months, 12 months and 24 months
Stent Cross-Sectional Area
Stent Cross-Sectional Area by OCT
Measured: 9 months
Minimum stent diameter
Minimum stent diameter by OCT
Measured: 9 months
Maximum stent diameter
Maximum stent diameter by OCT
Measured: 9 months
Intimal hyperplasia (IH) area
Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT
Measured: 9 months
Percentage of intimal hyperplasia
Percentage of intimal hyperplasia (IH area divided by stent area) by OCT
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start19 Oct 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixir Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Istituto Clinico Humanitas
- Responsible party
- Principal investigator, Dr. Antonio Colombo, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464147
- Sponsor's protocol ID
- 250521
- Acronym
- DYNAMITE
- Status last verified
- Aug 2025
- First submitted
- 13 Jul 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE Study)
- ClinicalTrials.gov ID
- NCT05464147
- Acronym / sponsor ID
- DYNAMITE / 250521
- Conditions
- Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery, Multi Vessel Coronary Artery Disease, Long Lesions Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Elixir Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Istituto Clinico Humanitas
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DynamX Drug-Eluting Coronary Bioadaptor System | Experimental | Device: DynamX Drug-Eluting Coronary Bioadaptor System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynamX Drug-Eluting Coronary Bioadaptor SystemDynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion | Device | DynamX Drug-Eluting Coronary Bioadaptor System |
Primary outcome
Change in mean in-device lumen area and mean device area
Time frame: Through 9 months
Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT)
10 secondary outcomes
Major Adverse Cardiac Event (MACE)
Time frame: 9 months, 12 months and 24 months
Cardiac Death (CD)
Time frame: 9 months, 12 months and 24 months
Myocardial Infarction (MI)
Time frame: 9 months, 12 months and 24 months
Target Lesion Revascularization (TLR)
Time frame: 9 months, 12 months and 24 months
Stent Thrombosis (ST)
Time frame: 9 months, 12 months and 24 months
Stent Cross-Sectional Area
Time frame: 9 months
Minimum stent diameter
Time frame: 9 months
Maximum stent diameter
Time frame: 9 months
Intimal hyperplasia (IH) area
Time frame: 9 months
Percentage of intimal hyperplasia
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynamX Drug-Eluting Coronary Bioadaptor System in people with Coronary Artery Disease and Chronic Total Occlusion of Coronary Artery, run by Elixir Medical Corporation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean in-device lumen area and mean device area (time frame: Through 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.