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

Running, not enrolling · Not applicable

Conditions studied: Acute Coronary Syndrome

In brief

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

Key facts

Study ID

NCT03716102

Run by

Svelte Medical Systems, Inc.

People needed

12

Starts

2018-11-21

Expected to finish

2021-07-15

Last updated by the study team

2020-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scottsdale Healthcare — Scottsdale, Arizona, United States
• Northern Michigan Hospital d.b.a McLaren Northern Michigan — Petoskey, Michigan, United States

Full record on ClinicalTrials.gov

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