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The primary objective of this multicenter, single-arm, observational study is to evaluate the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an all-comers, real-world population.
In this post-market study, the population will include real-world subjects who are intended to be treated, with SLENDER IDS as standard therapy. Follow-up contacts post procedure will be made for clinical assessments at hospital discharge, 1, 6 and 12 months.
This study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population. A minimum of two hundred fifty (250) subjects will be treated at up to 20 sites in Europe.
Review of safety data and risks to subjects will be monitored by an independent Clinical Events Committee (CEC) at pre-specified enrollment milestones.
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| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | composite endpoint of Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods. | Discharge, 1, 6 and 12 months |
| Major Adverse Cardiac Event (MACE) |
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Inclusion Criteria:
Exclusion Criteria:
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This study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Donohoe, MD | Svelte Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meander Medical Center | Amersfoort | Netherlands | ||||
| OLVG |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 18, 2021 | |
| Reset | Apr 14, 2021 | |
| Release | May 25, 2022 | |
| Reset | Feb 24, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2021 | Apr 14, 2021 | |||
| May 25, 2022 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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defined as a composite of all deaths, Target Vessel MI (Q wave and non-Q wave), emergent coronary artery bypass grafting surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
| Discharge, 1, 6 and 12 months |
| Amsterdam |
| 1091 AC |
| Netherlands |
| Tergooi Hospital | Blaricum | 1261AN | Netherlands |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Albert Schweitzer Hospital | Dordrecht | 3300 AK | Netherlands |
| St Antonius Hospital | Nieuwegein | 3430 EM | Netherlands |
| HagaZiekenhuis | The Hague | 2545 AA | Netherlands |
| University Medical Center | Utrecht | Netherlands |
| Feb 24, 2023 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |