This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions \< 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of Myolimus. * Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at baseline and at 6 months. * Optical Coherence Tomography (OCT) will will be completed for all patients at baseline and at 6 months. * Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12 and 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
AZ Middelheim Hospital
Antwerp, Belgium
Auckland City Hospital
Auckland, New Zealand
Mercy Angiography Unit
Auckland, New Zealand
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Time frame: 1 month
Clinically-Indicated Target Lesion Failure (CI-TLF)
Time frame: 1 month
Clinically-Indicated Target Vessel Failure (CI-TVF)
Time frame: 1 month
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Time frame: 1 month
Stent thrombosis
Time frame: 1 month
Acute success - Procedure success
Acute Success is classified according to the following definitions: Procedure success - Attainment of final result, \< 50% residual stenosis of the target site, using the DESolve Myolimus Eluting BCSS device without the occurrence of in-hospital any Major Adverse Cardiac Endpoints.
Time frame: 7 days
Acute success - Device success
Acute Success is classified according to the following definitions: Device success - Attainment of final result, \< 50% residual stenosis of the target site, using the study stent without the need for other non-study stents.
Time frame: 7 days
Stent thrombosis
Time frame: 6 months
Stent thrombosis
Time frame: 12 months
Stent thrombosis
Time frame: 2 years
Stent thrombosis
Time frame: 3 years
Stent thrombosis
Time frame: 4 years
Stent thrombosis
Time frame: 5 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Time frame: 6 months
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Time frame: 12 months
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Time frame: 2 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Time frame: 3 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Time frame: 4 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Time frame: 5 years
Clinically-Indicated Target Lesion Failure (CI-TLF)
Time frame: 6 months
Clinically-Indicated Target Lesion Failure (CI-TLF)
Time frame: 12 months
Clinically-Indicated Target Lesion Failure (CI-TLF)
Time frame: 2 years
Clinically-Indicated Target Lesion Failure (CI-TLF)
Time frame: 3 years
Clinically-Indicated Target Lesion Failure (CI-TLF)
Time frame: 4 years
Clinically-Indicated Target Lesion Failure (CI-TLF)
Time frame: 5 years
Clinically-Indicated Target Vessel Failure (CI-TVF)
Time frame: 6 months
Clinically-Indicated Target Vessel Failure (CI-TVF)
Time frame: 12 months
Clinically-Indicated Target Vessel Failure (CI-TVF)
Time frame: 2 years
Clinically-Indicated Target Vessel Failure (CI-TVF)
Time frame: 3 years
Clinically-Indicated Target Vessel Failure (CI-TVF)
Time frame: 4 years
Clinically-Indicated Target Vessel Failure (CI-TVF)
Time frame: 5 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Time frame: 6 months
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Time frame: 12 months
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Time frame: 2 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Time frame: 3 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Time frame: 4 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.