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

June 24, 2020 updated by: Svelte Medical Systems, Inc.
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare
    • Michigan
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital d.b.a McLaren Northern Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Svelte DES
Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug
Device: PCI with implantation with DES
PCI with implantation with DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed blood concentration (Cmax)
Time Frame: Up to 30 days
Up to 30 days
Time to reach maximum blood concentration (tmax)
Time Frame: Up to 30 days
Up to 30 days
Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)
Time Frame: Up to 30 days
Up to 30 days
Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞)
Time Frame: Up to 30 days
Up to 30 days
Terminal phase half-life (t1/2)
Time Frame: Up to 30 days
Up to 30 days
Apparent total blood clearance (CL/F)
Time Frame: Up to 30 days
Up to 30 days
Apparent volume of distribution (Vd/F)
Time Frame: Up to 30 days
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Target Vessel Failure (TVF)
Time Frame: 6 months, 12 months, 2 years
6 months, 12 months, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Svelte Medical Systems, Inc.

Investigators

  • Study Director: Dennis Donohoe, MD, Svelte Medical Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Actual)

June 15, 2020

Study Completion (Anticipated)

July 15, 2021

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-18-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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