Clinical Trials in the USA / NCT03716102
Active, not recruiting
Not applicable
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
NCT03716102 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Acute Coronary Syndrome
Investigational drug(s) / intervention(s)
PCI with implantation with DES
PCI with implantation with DES: PCI with implantation with DES
Study summary
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
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
Primary outcome measure(s)
- 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
- Apparent volume of distribution (Vd/F) — Up to 30 days
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | |
| Northern Michigan Hospital d.b.a McLaren Northern Michigan | Petoskey | Michigan |
Other trials for the same condition
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03716102 on ClinicalTrials.gov ↗ ← All trials in the USA