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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03716102
• Other study ID #: IP-18-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: July 15, 2021

Study information

• Verified date: June 2020
• Source: Svelte Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: July 15, 2021
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Device:
• PCI with implantation with DES
PCI with implantation with DES

Locations

Country	Name	City	State
United States	Northern Michigan Hospital d.b.a McLaren Northern Michigan	Petoskey	Michigan
United States	Scottsdale Healthcare	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Svelte Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed blood concentration (Cmax)		Up to 30 days
Primary	Time to reach maximum blood concentration (tmax)		Up to 30 days
Primary	Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)		Up to 30 days
Primary	Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-8)		Up to 30 days
Primary	Terminal phase half-life (t1/2)		Up to 30 days
Primary	Apparent total blood clearance (CL/F)		Up to 30 days
Primary	Apparent volume of distribution (Vd/F)		Up to 30 days
Secondary	Target Vessel Failure (TVF)		6 months, 12 months, 2 years