DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
DYNAMITE
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Oct 2021
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2021
CompletedFirst Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedSeptember 21, 2023
September 1, 2023
2.4 years
July 13, 2022
September 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Through 9 months
Secondary Outcomes (10)
Major Adverse Cardiac Event (MACE)
9 months, 12 months and 24 months
Cardiac Death (CD)
9 months, 12 months and 24 months
Myocardial Infarction (MI)
9 months, 12 months and 24 months
Target Lesion Revascularization (TLR)
9 months, 12 months and 24 months
Stent Thrombosis (ST)
9 months, 12 months and 24 months
- +5 more secondary outcomes
Study Arms (1)
DynamX Drug-Eluting Coronary Bioadaptor System
EXPERIMENTALInterventions
DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elixir Medical Corporationlead
- Istituto Clinico Humanitascollaborator
Study Sites (1)
Humanitas Research Hospital
Rozzano, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All imaging analyses will be performed at an independent core laboratory (Cardiovascular Department, San Giovanni Addolorata Hospital, Rome, Italy) by experienced operators blinded to procedural data and clinical outcomes.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Antionio Colombo, Senior Consultant - Cardio Center, Clinical and Interventional Cardiology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 19, 2022
Study Start
October 19, 2021
Primary Completion
March 1, 2024
Study Completion
October 1, 2024
Last Updated
September 21, 2023
Record last verified: 2023-09