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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DESolve scaffold | Other | DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DESolve Novolimus Eluting Bioresorbable Coronary Scaffold | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) | 1 month | |
| Clinically-Indicated Target Lesion Failure (CI-TLF) | 1 month | |
| Clinically-Indicated Target Vessel Failure (CI-TVF) | 1 month | |
| Clinically-Indicated Target Vessel Revascularization (CI-TVR) | 1 month | |
| Stent thrombosis | 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. | 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. | 7 days |
| Stent thrombosis | 6 months | |
| Stent thrombosis | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Ormiston, MD | Auckland City Hospital and Mercy Angiography Unit | Principal Investigator |
| Stefan Verheye, MD, PhD | ZNA Middelheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Middelheim Hospital | Antwerp | 2020 | Belgium | |||
| Auckland City Hospital |
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| Stent thrombosis |
| 2 years |
| Stent thrombosis | 3 years |
| Stent thrombosis | 4 years |
| Stent thrombosis | 5 years |
| Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) | 6 months |
| Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) | 12 months |
| Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) | 2 years |
| Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) | 3 years |
| Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) | 4 years |
| Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) | 5 years |
| Clinically-Indicated Target Lesion Failure (CI-TLF) | 6 months |
| Clinically-Indicated Target Lesion Failure (CI-TLF) | 12 months |
| Clinically-Indicated Target Lesion Failure (CI-TLF) | 2 years |
| Clinically-Indicated Target Lesion Failure (CI-TLF) | 3 years |
| Clinically-Indicated Target Lesion Failure (CI-TLF) | 4 years |
| Clinically-Indicated Target Lesion Failure (CI-TLF) | 5 years |
| Clinically-Indicated Target Vessel Failure (CI-TVF) | 6 months |
| Clinically-Indicated Target Vessel Failure (CI-TVF) | 12 months |
| Clinically-Indicated Target Vessel Failure (CI-TVF) | 2 years |
| Clinically-Indicated Target Vessel Failure (CI-TVF) | 3 years |
| Clinically-Indicated Target Vessel Failure (CI-TVF) | 4 years |
| Clinically-Indicated Target Vessel Failure (CI-TVF) | 5 years |
| Clinically-Indicated Target Vessel Revascularization (CI-TVR) | 6 months |
| Clinically-Indicated Target Vessel Revascularization (CI-TVR) | 12 months |
| Clinically-Indicated Target Vessel Revascularization (CI-TVR) | 2 years |
| Clinically-Indicated Target Vessel Revascularization (CI-TVR) | 3 years |
| Clinically-Indicated Target Vessel Revascularization (CI-TVR) | 4 years |
| Clinically-Indicated Target Vessel Revascularization (CI-TVR) | 5 years |
| Auckland |
| 1023 |
| New Zealand |
| Mercy Angiography Unit | Auckland | 1023 | New Zealand |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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