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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-21

Study Completion Date

2021-07-15

Brief Summary

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To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Svelte DES

Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug

Group Type EXPERIMENTAL

PCI with implantation with DES

Intervention Type DEVICE

PCI with implantation with DES

Interventions

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PCI with implantation with DES

Intervention Type DEVICE

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

Exclusion Criteria

* Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No