OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Not Applicable
Active, not recruiting
- Conditions
- Acute Coronary Syndrome
- Interventions
- Device: PCI with implantation with DES
- Registration Number
- NCT03716102
- Lead Sponsor
- Svelte Medical Systems, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Svelte DES PCI with implantation with DES Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug
- Primary Outcome Measures
Name Time Method Time to reach maximum blood concentration (tmax) Up to 30 days Apparent volume of distribution (Vd/F) Up to 30 days Maximum observed blood concentration (Cmax) Up to 30 days Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t) Up to 30 days Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞) Up to 30 days Terminal phase half-life (t1/2) Up to 30 days Apparent total blood clearance (CL/F) Up to 30 days
- Secondary Outcome Measures
Name Time Method Target Vessel Failure (TVF) 6 months, 12 months, 2 years
Trial Locations
- Locations (2)
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Northern Michigan Hospital d.b.a McLaren Northern Michigan
🇺🇸Petoskey, Michigan, United States