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OPTIMIZE IDE for the Treatment of ACS (OPTIMIZE)

Primary Purpose

Acute Coronary Syndrome

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DES
Sponsored by
Svelte Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Thomas Hospital
  • Scottsdale Healthcare
  • Arkansas Heart Hospital
  • Bakersfield Memorial Hospital
  • Mission Cardiovascular Research Institute (Washington Hospital)
  • Long Beach VA Medical Center
  • Keck Hospital of USC
  • San Francisco VA
  • Christiana Hospital
  • Morton Plant Hospital
  • Clearwater Cardiovascular Consultants
  • Memorial Regional Hospital
  • University of Miami Medical Center
  • Mediquest (Munroe Regional Medical Center)
  • Tallahassee Research Institute
  • Jesse Brown VAMC
  • University of Chicago Medical Center
  • Amita/Adventist Heart and Vascular
  • Elkhart General Healthcare
  • St Vincent Heart Center of Indiana
  • Mercy Hospital Medical Center
  • Union Memorial Hospital
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Borgess Heart Center
  • Northern Michigan Hospital d.b.a McLaren Northern Michigan
  • William Beaumont Hospital
  • St. Mary's Duluth Clinic
  • Mayo Clinic
  • North Mississippi Health Services
  • St. Luke's Hospital
  • Washington University School of Medicine
  • Deborah Heart and Lung Center
  • Morristown Medical Center
  • Montefiore Medical Center
  • NYU Winthrop Hospital
  • NYU Langone Medical Center
  • Weill Cornell Medical Center
  • Rochester General Hospital
  • St. Joseph's Hospital Health Center
  • Durham VA Medical Center
  • Moses Cone Memorial Hospital
  • North Carolina Heart and Vascular
  • The Christ Hospital
  • Riverside Methodist Hospital
  • Lehigh Valley Hospital
  • Hershey Medical Center
  • Robert Packer Hospital
  • Texas Heart Institute
  • The Methodist Hospital
  • Austin Heart
  • South Texas Cardiology Institute
  • University of Virginia Medical Center
  • Swedish Hospital Medical Center
  • Shonan Kamakura General Hospital
  • Kanazawa Cardiovascular Hospital
  • Kokura Memorial Hospital
  • Medical Corporation Association Sakura Association Takahashi Hospital
  • Ohara Healthcare Foundation Kurashiki Central Hospital
  • Shin Koga Hospital
  • Miyazaki Medical Association
  • The Sakakibara Heart Institute of Okayama
  • Sapporo Higashi Tokushukai Hospital
  • Meander Medisch Centrum
  • OLVG loc Oost
  • Tergooi Ziekenhuis
  • Amphia Ziekenhuis
  • HAGA Ziekenhuis
  • Albert Schweitzer Ziekenhuis
  • Catharina Ziekenhuis
  • St Antonius Ziekenhuis
  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Svelte

Control

Arm Description

Outcomes

Primary Outcome Measures

Target Lesion Failure (TLF)

Secondary Outcome Measures

Target Vessel Failure (TVF)
Major Adverse Cardiac Event (MACE)
Stent Thrombosis

Full Information

First Posted
June 14, 2017
Last Updated
March 21, 2023
Sponsor
Svelte Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03190473
Brief Title
OPTIMIZE IDE for the Treatment of ACS
Acronym
OPTIMIZE
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Company financial insolvency, not due to safety or efficacy concerns
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
July 17, 2020 (Actual)
Study Completion Date
March 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Svelte Medical Systems, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Svelte
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
DES
Intervention Description
PCI with implantation of a DES
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Target Vessel Failure (TVF)
Time Frame
6 and 12 months, and annually through 5 years
Title
Major Adverse Cardiac Event (MACE)
Time Frame
6 and 12 months and annually through 5 years follow-up
Title
Stent Thrombosis
Time Frame
6 and 12 months and annually through 5 years follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shing C Wong, MD
Organizational Affiliation
Svelte Medical
Official's Role
Study Director
Facility Information:
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Bakersfield Memorial Hospital
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Mission Cardiovascular Research Institute (Washington Hospital)
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Long Beach VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
San Francisco VA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19702
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clearwater Cardiovascular Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Miami Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Mediquest (Munroe Regional Medical Center)
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32303
Country
United States
Facility Name
Jesse Brown VAMC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Amita/Adventist Heart and Vascular
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Elkhart General Healthcare
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
St Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Mercy Hospital Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Borgess Heart Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Northern Michigan Hospital d.b.a McLaren Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
St. Mary's Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
North Mississippi Health Services
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
St. Joseph's Hospital Health Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Moses Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
North Carolina Heart and Vascular
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Austin Heart
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
South Texas Cardiology Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Hospital Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Shonan Kamakura General Hospital
City
Kamakura
Country
Japan
Facility Name
Kanazawa Cardiovascular Hospital
City
Kanazawa
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
Country
Japan
Facility Name
Medical Corporation Association Sakura Association Takahashi Hospital
City
Kobe
Country
Japan
Facility Name
Ohara Healthcare Foundation Kurashiki Central Hospital
City
Kurashiki
Country
Japan
Facility Name
Shin Koga Hospital
City
Kurume
Country
Japan
Facility Name
Miyazaki Medical Association
City
Miyazaki
Country
Japan
Facility Name
The Sakakibara Heart Institute of Okayama
City
Okayama
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
Country
Japan
Facility Name
Meander Medisch Centrum
City
Amersfoort
Country
Netherlands
Facility Name
OLVG loc Oost
City
Amsterdam
Country
Netherlands
Facility Name
Tergooi Ziekenhuis
City
Blaricum
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
HAGA Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34353122
Citation
Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, Amoroso G, Zidar JP, Wong SC, Stella P, Yakubov S, Lasala J, Cohen DJ, Doros G, Cutlip DE, Rao SV. Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study. Circ Cardiovasc Interv. 2021 Sep;14(9):e010609. doi: 10.1161/CIRCINTERVENTIONS.121.010609. Epub 2021 Aug 6.
Results Reference
derived
PubMed Identifier
31415994
Citation
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.
Results Reference
derived

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OPTIMIZE IDE for the Treatment of ACS

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