DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
NCT ID: NCT05464147
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
55 participants
INTERVENTIONAL
2021-10-19
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DynamX Drug-Eluting Coronary Bioadaptor System
DynamX Drug-Eluting Coronary Bioadaptor System
DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion
Interventions
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DynamX Drug-Eluting Coronary Bioadaptor System
DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Elixir Medical Corporation
INDUSTRY
Responsible Party
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Dr. Antonio Colombo
Dr. Antionio Colombo, Senior Consultant - Cardio Center, Clinical and Interventional Cardiology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy
Locations
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Humanitas Research Hospital
Rozzano, , Italy
Countries
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Other Identifiers
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250521
Identifier Type: -
Identifier Source: org_study_id
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