DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System
NCT ID: NCT06074549
Last Updated: 2025-08-28
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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RECRUITING
5000 participants
OBSERVATIONAL
2024-03-10
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Open Label
DynamX Novolimus-eluting Coronary Bioadaptor System
DynamX Novolimus-eluting Coronary Bioadaptor System
All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use
Interventions
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DynamX Novolimus-eluting Coronary Bioadaptor System
All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient understands the trial requirements and treatment procedures and provides informed consent
3. Patient indicated for PCI with stent implantation and receive at least one DynamX Bioadaptor implant in accordance with the product's Instructions for Use (IFU).
Exclusion Criteria
2. Prior venous or arterial bypass grafts
3. In-stent restenosis
4. Patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (e.g., anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint
5. Patient is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the registry for any reason
18 Years
ALL
No
Sponsors
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Elixir Medical Corporation
INDUSTRY
Responsible Party
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Locations
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University Hospital St. Pölten
Pölten, , Austria
Curaçao Medical Center
Willemstad, , Curacao
Heartology Cardiovascular Hospital
Jakarta, , Indonesia
Jakarta Heart Center
Jakarta, , Indonesia
Medistra Hospital
Jakarta, , Indonesia
Siloam Hospitals
Jakarta, , Indonesia
Centro Cardiologico Monzino
Milan, , Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, , Italy
Policlinico Tor Vergata
Rome, , Italy
Jordon Hospital
Amman, , Jordan
The Specialty Hospital
Amman, , Jordan
King Fahad Armed Forces Hospital
Jeddah, , Saudi Arabia
Istanbul Medipol Mega University Hospital
Istanbul, , Turkey (Türkiye)
Memorial Bahçelievler Hospital
Istanbul, , Turkey (Türkiye)
Al Qassimi Hospital
Sharjah city, , United Arab Emirates
Tam Duc Heart Hospital
Ho Chi Minh City, , Vietnam
Kiến Giang General Hospital
Kiến Giang, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Julia Mascherbauer, MD
Role: primary
Jose Torres, MD
Role: primary
Dafsah Juzar, MD
Role: primary
Todung Silalahi, MD
Role: primary
Teguh Santoso, MD
Role: primary
Antonia Lukito, MD
Role: primary
Stefano Galli, MD
Role: primary
Giovanni Esposito, MD
Role: primary
Giuseppe Sangiorgi, MD
Role: primary
Imad Alhaddad, MD
Role: primary
Mazen Sudqi, MD
Role: primary
Mirvat Alasnag, MD
Role: primary
Bilal Boztosun, MD
Role: primary
Omer Goktekin, MD
Role: primary
Arif Al Nooryani, MD
Role: primary
Nguyen Huynh Khuong, MD
Role: primary
Huynh Trung Cang, MD
Role: primary
Other Identifiers
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ELX-CL-2002
Identifier Type: -
Identifier Source: org_study_id
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