OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study

Study Overview
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Brief Summary
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To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

Detailed Description
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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.

Official Title
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OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: PCI with implantation with DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is an eligible candidate for PCI Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia Subject is an acceptable candidate for CABG Subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm Exclusion Criteria: Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina Subject's target lesion(s) is located in the left main coronary artery Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX coronary artery Subject's target lesion(s) is located within a SVG or an arterial graft Subject's target lesion(s) will be accessed via SVG or arterial graft

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Svelte DES<br>Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug | Device: PCI with implantation with DES<br>* PCI with implantation with DES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) |  | 6 months, 12 months, 2 years |