To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion and up to one non-target lesion located in a separate epicardial vessel.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
percutaneous coronary
AZ Middelheim Hospital
Antwerp, Belgium
St. - Jan Ziekenhuis Z.O.L.
Genk, Belgium
Instituto Dante Pazzanese
São Paulo, Brazil
Clinically-indicated major adverse cardiac events (MACE)
cardiac death, target vessel MI, clinically indicated TLR
Time frame: 6 months
Late Lumen Loss
MLD post procedure - MLD at follow-up
Time frame: 6 month
Major Adverse Cardiac Events
cardiac death, target vessel MI, clinically indicated TLR
Time frame: 1 month
Major Adverse Cardiac Events
cardiac death, target vessel MI, clinically indicated TLR
Time frame: 12 months
Major Adverse Cardiac Events
cardiac death, target vessel MI, clinically indicated TLR
Time frame: 24 months
Major Adverse Cardiac Events
cardiac death, target vessel MI, clinically indicated TLR
Time frame: 3 years
Major Adverse Cardiac Events
cardiac death, target vessel MI, clinically indicated TLR
Time frame: 4 years
Major Adverse Cardiac Events
cardiac death, target vessel MI, clinically indicated TLR
Time frame: 5 months
Clinically-Indicated Target Lesion Failure (TLF)
cardiac death, MI, clinically indicated TLR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ICT / Instituto Do Coracao Do Triangulo Mineiro
Uberlândia, Brazil
Aarhus University Hospital, Skejby
Aarhus N, Denmark
Charite - Campus Benjamin Franklin
Berlin, Germany
Universitäres Herz- und Gefäßzentrum
Hamburg, Germany
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
Mercy Angiography Unit
Auckland, New Zealand
...and 3 more locations
Time frame: 1 month
Clinically-Indicated Target Lesion Failure (TLF)
cardiac death, MI, clinically indicated TLR
Time frame: 6 months
Clinically-Indicated Target Lesion Failure (TLF)
cardiac death, MI, clinically indicated TLR
Time frame: 1 year
Clinically-Indicated Target Lesion Failure (TLF)
cardiac death, MI, clinically indicated TLR
Time frame: 2 years
Clinically-Indicated Target Lesion Failure (TLF)
cardiac death, MI, clinically indicated TLR
Time frame: 3 years
Clinically-Indicated Target Lesion Failure (TLF)
cardiac death, MI, clinically indicated TLR
Time frame: 4 years
Clinically-Indicated Target Lesion Failure (TLF)
cardiac death, MI, clinically indicated TLR
Time frame: 5 years
Clinically-Indicated Target Vessel Failure (TVF)
cardiac death, MI, clinically indicated TVR
Time frame: 1 year
Clinically-Indicated Target Vessel Failure (TVF)
cardiac death, MI, clinically indicated TLR
Time frame: 2 years
Clinically-Indicated Target Vessel Failure (TVF)
cardiac death, MI, clinically indicated TLR
Time frame: 3 years
Clinically-Indicated Target Vessel Failure (TVF)
cardiac death, MI, clinically indicated TLR
Time frame: 4 years
Clinically-Indicated Target Vessel Failure (TVF)
cardiac death, MI, clinically indicated TLR
Time frame: 5 years
Scaffold Thrombosis
ARC defined
Time frame: through 5 years