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OpenTrials
Active, Not Recruiting

NCT Number: NCT03716102

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

To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scottsdale Healthcare, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI with implantation with DES

Device

PCI with implantation with DES

Primary outcomes

  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 outcomes

  1. Target Vessel Failure (TVF)

    Time frame: 6 months, 12 months, 2 years

Sponsors and collaborators

Lead sponsor

Svelte Medical Systems, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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