Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Not applicable

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

NCT03716102 · tracked via the Priya Life Science USA tracker
Sponsor
Svelte Medical Systems, Inc
Phase
Not applicable
Started
2018-11-21
Last updated
2020-06-26

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

Sex
ALL
Min age
18 Years
Max age
—
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 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)

FacilityCityRegionStatus
Scottsdale Healthcare Scottsdale Arizona
Northern Michigan Hospital d.b.a McLaren Northern Michigan Petoskey Michigan
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