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OPTIMIZE IDE for the Treatment of ACS (OPTIMIZE)

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: NCT03190473
Recruitment Status : Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Svelte Medical Systems, Inc.

Study Description
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Brief Summary:
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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : June 28, 2020
Estimated Study Completion Date : June 28, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Svelte Device: DES
PCI with implantation of a DES
Active Comparator: Control Device: DES
PCI with implantation of a DES


Outcome Measures
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Primary Outcome Measures :
  1. Target Lesion Failure (TLF) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Target Vessel Failure (TVF) [ Time Frame: 6 and 12 months, and annually through 5 years ]
  2. Major Adverse Cardiac Event (MACE) [ Time Frame: 6 and 12 months and annually through 5 years follow-up ]
  3. Stent Thrombosis [ Time Frame: 6 and 12 months and annually through 5 years follow-up ]

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 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;
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): NCT03190473


Locations
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Sponsors and Collaborators
Svelte Medical Systems, Inc.
Investigators
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Study Director: Dennis Donohoe, MD Svelte Medical
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Svelte Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT03190473    
Other Study ID Numbers: IP-15-001
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 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