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

Primary Purpose

Acute Coronary Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCI with implantation with DES
Sponsored by
Svelte Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scottsdale Healthcare
  • Northern Michigan Hospital d.b.a McLaren Northern Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Svelte DES

Arm Description

Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Target Vessel Failure (TVF)

Full Information

First Posted
October 18, 2018
Last Updated
June 24, 2020
Sponsor
Svelte Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03716102
Brief Title
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Official Title
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
July 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Svelte Medical Systems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Svelte DES
Arm Type
Experimental
Arm Description
Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug
Intervention Type
Device
Intervention Name(s)
PCI with implantation with DES
Intervention Description
PCI with implantation with DES
Primary Outcome Measure Information:
Title
Maximum observed blood concentration (Cmax)
Time Frame
Up to 30 days
Title
Time to reach maximum blood concentration (tmax)
Time Frame
Up to 30 days
Title
Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)
Time Frame
Up to 30 days
Title
Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞)
Time Frame
Up to 30 days
Title
Terminal phase half-life (t1/2)
Time Frame
Up to 30 days
Title
Apparent total blood clearance (CL/F)
Time Frame
Up to 30 days
Title
Apparent volume of distribution (Vd/F)
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Target Vessel Failure (TVF)
Time Frame
6 months, 12 months, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Donohoe, MD
Organizational Affiliation
Svelte Medical Systems
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Northern Michigan Hospital d.b.a McLaren Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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