OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
1 other identifier
interventional
12
1 country
2
Brief Summary
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
November 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2021
CompletedJune 26, 2020
June 1, 2020
1.6 years
October 18, 2018
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
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
Secondary Outcomes (1)
Target Vessel Failure (TVF)
6 months, 12 months, 2 years
Study Arms (1)
Svelte DES
EXPERIMENTALStent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Northern Michigan Hospital d.b.a McLaren Northern Michigan
Petoskey, Michigan, 49770, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dennis Donohoe, MD
Svelte Medical Systems
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2018
First Posted
October 23, 2018
Study Start
November 21, 2018
Primary Completion
June 15, 2020
Study Completion
July 15, 2021
Last Updated
June 26, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share