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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716102
Recruitment Status : Active, not recruiting
First Posted : October 23, 2018
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Svelte Medical Systems, Inc.

Study Description
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Brief Summary:
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: PCI with implantation with DES Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : June 15, 2020
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. Target Vessel Failure (TVF) [ Time Frame: 6 months, 12 months, 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716102


Locations
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United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Michigan
Northern Michigan Hospital d.b.a McLaren Northern Michigan
Petoskey, Michigan, United States, 49770
Sponsors and Collaborators
Svelte Medical Systems, Inc.
Investigators
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Study Director: Dennis Donohoe, MD Svelte Medical Systems
More Information
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Responsible Party: Svelte Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT03716102    
Other Study ID Numbers: IP-18-001
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases