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

Svelte Medical Systems

Status

Active, not recruiting

Conditions

Acute Coronary Syndrome

Treatments

Device: PCI with implantation with DES

Study type

Interventional

Funder types

Industry

Identifiers

NCT03716102

IP-18-001

Details and patient eligibility

About

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

Full description

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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