Last updated: April 22, 2024
Sponsor: Elixir Medical Corporation
Overall Status: Active - Recruiting
Phase
N/A
Condition
Heart Disease
Vascular Diseases
Atherosclerosis
Treatment
DynamX Novolimus-eluting Coronary Bioadaptor System
Clinical Study ID
NCT06074549
ELX-CL-2002
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Over 18 years of age
- Patient understands the trial requirements and treatment procedures and providesinformed consent
- Patient indicated for PCI with stent implantation and receive at least one DynamXBioadaptor implant in accordance with the product's Instructions for Use (IFU).
Exclusion
Exclusion Criteria:
- Target Lesion(s) in the left main artery
- Prior venous or arterial bypass grafts
- In-stent restenosis
- Patient is currently participating in another clinical trial with an investigationaldevice 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 itsprimary endpoint
- Patient is, in the opinion of the Investigator, unable to comply with the requirementsof the study protocol or is unsuitable for the registry for any reason
Study Design
Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: DynamX Novolimus-eluting Coronary Bioadaptor System
Phase:
Study Start date:
March 10, 2024
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
King Fahad Armed Forces Hospital
Jeddah, 23311
Saudi ArabiaActive - Recruiting
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