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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 : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Svelte Medical Systems, Inc.

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE June 16, 2017
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE January 2, 2018
Actual Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
Target Lesion Failure (TLF) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • Target Vessel Failure (TVF) [ Time Frame: 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 ]
  • Stent Thrombosis [ Time Frame: 6 and 12 months and annually through 5 years follow-up ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OPTIMIZE IDE for the Treatment of ACS
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE Device: DES
PCI with implantation of a DES
Study Arms  ICMJE
  • Experimental: Svelte
    Intervention: Device: DES
  • Active Comparator: Control
    Intervention: Device: DES
Publications * Mauri L, Doros G, Rao SV, Cohen DJ, Yakubov S, Lasala J, Wong SC, Zidar J, Kereiakes DJ. The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale. Am Heart J. 2019 Oct;216:82-90. doi: 10.1016/j.ahj.2019.07.003. Epub 2019 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 28, 2017)
1630
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 28, 2024
Actual Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03190473
Other Study ID Numbers  ICMJE IP-15-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Svelte Medical Systems, Inc.
Study Sponsor  ICMJE Svelte Medical Systems, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dennis Donohoe, MD Svelte Medical
PRS Account Svelte Medical Systems, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP