Acute Coronary Syndrome
Conditions
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.
Interventions
DEVICEPCI with implantation with DES
PCI with implantation with DES
Sponsors
Svelte Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apparent volume of distribution (Vd/F) | Up to 30 days |
| Maximum observed blood concentration (Cmax) | Up to 30 days |
| Time to reach maximum blood concentration (tmax) | 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
| Measure | Time frame |
|---|---|
| Target Vessel Failure (TVF) | 6 months, 12 months, 2 years |
Countries
United States
Outcome results
None listed