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To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Svelte DES | Experimental | Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI with implantation with DES | Device | PCI with implantation with DES |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed blood concentration (Cmax) | Up to 30 days | |
| Time to reach maximum blood concentration (tmax) | Up to 30 days | |
| Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t) | Up to 30 days | |
| Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞) | Up to 30 days | |
| Terminal phase half-life (t1/2) | Up to 30 days | |
| Apparent total blood clearance (CL/F) | Up to 30 days | |
| Apparent volume of distribution (Vd/F) | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | 6 months, 12 months, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Donohoe, MD | Svelte Medical Systems | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
| Northern Michigan Hospital d.b.a McLaren Northern Michigan |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 27, 2022 | Nov 18, 2022 | 5 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Single Group Assignment
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| Petoskey |
| Michigan |
| 49770 |
| United States |
| D019060 | Minimally Invasive Surgical Procedures |