Clinical trial NCT03716102: OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Official title: OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Svelte Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed blood concentration (Cmax)
timeFrame: Up to 30 days
measure: Time to reach maximum blood concentration (tmax)
timeFrame: Up to 30 days
measure: Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)
timeFrame: Up to 30 days
measure: Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞)
timeFrame: Up to 30 days
measure: Terminal phase half-life (t1/2)
timeFrame: Up to 30 days
measure: Apparent total blood clearance (CL/F)
timeFrame: Up to 30 days
measure: Apparent volume of distribution (Vd/F)
timeFrame: Up to 30 days
Secondary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 6 months, 12 months, 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Petoskey
country: United States
facility: Northern Michigan Hospital d.b.a McLaren Northern Michigan
state: Michigan
Study officials:
affiliation: Svelte Medical Systems
name: Dennis Donohoe, MD
role: STUDY_DIRECTOR
References: