OPTIMIZE IDE for the Treatment of ACS (OPTIMIZE)

March 21, 2023 updated by: Svelte Medical Systems, Inc.

The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1630

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Japan
      • Kamakura, Japan
        • Shonan Kamakura General Hospital
      • Kanazawa, Japan
        • Kanazawa Cardiovascular Hospital
      • Kitakyushu, Japan
        • Kokura Memorial Hospital
      • Kobe, Japan
        • Medical Corporation Association Sakura Association Takahashi Hospital
      • Kurashiki, Japan
        • Ohara HealthCare Foundation Kurashiki Central Hospital
      • Kurume, Japan
        • Shin Koga Hospital
      • Miyazaki, Japan
        • Miyazaki Medical Association
      • Okayama, Japan
        • The Sakakibara Heart Institute of Okayama
      • Sapporo, Japan
        • Sapporo Higashi Tokushukai Hospital
  • Netherlands
      • Amersfoort, Netherlands
        • Meander Medisch Centrum
      • Amsterdam, Netherlands
        • OLVG loc Oost
      • Blaricum, Netherlands
        • Tergooi Ziekenhuis
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Den Haag, Netherlands
        • Haga Ziekenhuis
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands
        • St Antonius Ziekenhuis
      • Utrecht, Netherlands
        • UMC Utrecht
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Thomas Hospital
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • Bakersfield, California, United States, 93301
        • Bakersfield Memorial Hospital
      • Fremont, California, United States, 94538
        • Mission Cardiovascular Research Institute (Washington Hospital)
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • San Francisco, California, United States, 94121
        • San Francisco VA
    • Delaware
      • Newark, Delaware, United States, 19702
        • Christiana Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Clearwater, Florida, United States, 34695
        • Clearwater Cardiovascular Consultants
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Miami, Florida, United States, 33125
        • University of Miami Medical Center
      • Ocala, Florida, United States, 34471
        • Mediquest (Munroe Regional Medical Center)
      • Tallahassee, Florida, United States, 32303
        • Tallahassee Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60637
        • Jesse Brown VAMC
      • Hinsdale, Illinois, United States, 60521
        • Amita/Adventist Heart and Vascular
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Elkhart General Healthcare
      • Indianapolis, Indiana, United States, 46290
        • St Vincent Heart Center of Indiana
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Hospital Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Borgess Heart Center
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital d.b.a McLaren Northern Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's Duluth Clinic
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Health Services
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital Health Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
      • Greensboro, North Carolina, United States, 27401
        • Moses Cone Memorial Hospital
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Heart and Vascular
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 19103
        • Lehigh Valley Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
      • Round Rock, Texas, United States, 78681
        • Austin Heart
      • San Antonio, Texas, United States, 78212
        • South Texas Cardiology Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Hospital Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is an eligible candidate for percutaneous coronary intervention (PCI);
  • Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
  • Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
  • Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 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 a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;

Exclusion Criteria:

  • The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
  • The subject's target lesion(s) is located in the left main artery;
  • The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;
  • The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
  • The subject's target lesion(s) will be accessed via a saphenous vein graft 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
Device: DES
PCI with implantation of a DES
Experimental: Svelte
Device: DES
PCI with implantation of a DES

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Target Lesion Failure (TLF)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Target Vessel Failure (TVF)
Time Frame: 6 and 12 months, and annually through 5 years
6 and 12 months, and annually through 5 years
Major Adverse Cardiac Event (MACE)
Time Frame: 6 and 12 months and annually through 5 years follow-up
6 and 12 months and annually through 5 years follow-up
Stent Thrombosis
Time Frame: 6 and 12 months and annually through 5 years follow-up
6 and 12 months and annually through 5 years follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Svelte Medical Systems, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shing C Wong, MD, Svelte Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IP-15-001

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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