Acute Coronary SyndromeOPTIMIZENCT03190473

OPTIMIZE IDE for the Treatment of ACS

A study testing DES in people with Acute Coronary Syndrome, run by Svelte Medical Systems, Inc. at 72 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: DES
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,630 participants
Where: 72 sitesin 3 countries
Study dates: 2 Jan 2018to 8 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

Trial locations and contacts

72 sites in 3 countries.

Country

City, postcode or hospital

72 sites in 3 countries

United States54 sites

Lehigh Valley Hospital
Allentown, Pennsylvania, 19103
Bakersfield Memorial Hospital
Bakersfield, California, 93301
Union Memorial Hospital
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Jesse Brown VAMC
Chicago, Illinois, 60637
University of Chicago Medical Center
Chicago, Illinois, 60637
The Christ Hospital
Cincinnati, Ohio, 45219
Morton Plant Hospital
Clearwater, Florida, 33756
Clearwater Cardiovascular Consultants
Clearwater, Florida, 34695
Riverside Methodist Hospital
Columbus, Ohio, 43214
Mercy Hospital Medical Center
Des Moines, Iowa, 50314
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805
Durham VA Medical Center
Durham, North Carolina, 27705
Elkhart General Healthcare
Elkhart, Indiana, 46514
Thomas Hospital
Fairhope, Alabama, 36532
Mission Cardiovascular Research Institute (Washington Hospital)
Fremont, California, 94538
Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401
Hershey Medical Center
Hershey, Pennsylvania, 17033
Amita/Adventist Heart and Vascular
Hinsdale, Illinois, 60521
Memorial Regional Hospital
Hollywood, Florida, 33021
Texas Heart Institute
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
St Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
Borgess Heart Center
Kalamazoo, Michigan, 49008
St. Luke's Hospital
Kansas City, Missouri, 64111
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Long Beach VA Medical Center
Long Beach, California, 90822
Keck Hospital of USC
Los Angeles, California, 90033
University of Miami Medical Center
Miami, Florida, 33125
NYU Winthrop Hospital
Mineola, New York, 11501
Morristown Medical Center
Morristown, New Jersey, 07960
NYU Langone Medical Center
New York, New York, 10016
Weill Cornell Medical Center
New York, New York, 10021
Christiana Hospital
Newark, Delaware, 19702
Mediquest (Munroe Regional Medical Center)
Ocala, Florida, 34471
Northern Michigan Hospital d.b.a McLaren Northern Michigan
Petoskey, Michigan, 49770
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607
Mayo Clinic
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York, 14621
Austin Heart
Round Rock, Texas, 78681
William Beaumont Hospital
Royal Oak, Michigan, 48073
South Texas Cardiology Institute
San Antonio, Texas, 78212
San Francisco VA
San Francisco, California, 94121
Robert Packer Hospital
Sayre, Pennsylvania, 18840
Scottsdale Healthcare
Scottsdale, Arizona, 85258
Swedish Hospital Medical Center
Seattle, Washington, 98122
Washington University School of Medicine
St Louis, Missouri, 63110
St. Joseph's Hospital Health Center
Syracuse, New York, 13203
Tallahassee Research Institute
Tallahassee, Florida, 32303
Montefiore Medical Center
The Bronx, New York, 10467
North Mississippi Health Services
Tupelo, Mississippi, 38801

Other trials in United States

Japan9 sites

Shonan Kamakura General Hospital
Kamakura
Kanazawa Cardiovascular Hospital
Kanazawa
Kokura Memorial Hospital
Kitakyushu
Medical Corporation Association Sakura Association Takahashi Hospital
Kobe
Ohara Healthcare Foundation Kurashiki Central Hospital
Kurashiki
Shin Koga Hospital
Kurume
Miyazaki Medical Association
Miyazaki
The Sakakibara Heart Institute of Okayama
Okayama
Sapporo Higashi Tokushukai Hospital
Sapporo

Other trials in Japan

Netherlands9 sites

Meander Medisch Centrum
Amersfoort
OLVG loc Oost
Amsterdam
Tergooi Ziekenhuis
Blaricum
Amphia Ziekenhuis
Breda
Albert Schweitzer Ziekenhuis
Dordrecht
Catharina Ziekenhuis
Eindhoven
St Antonius Ziekenhuis
Nieuwegein
HAGA Ziekenhuis
The Hague
UMC Utrecht
Utrecht

Other trials in Netherlands

About this study

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

Conditions: Acute Coronary Syndrome
Being tested: DES
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DESDevice
PCI with implantation of a DES

Study groups in NCT03190473
Study group	Role	What they receive
Svelte	Experimental	Not described Receives: Device: DES
Control	Active comparator	Not described Receives: Device: DES

What is being measured

The primary outcome is the main question the study is designed to answer.

Target Lesion Failure (TLF)
Measured: 12 months

Secondary outcomes (3)

Target Vessel Failure (TVF)
Measured: 6 and 12 months, and annually through 5 years
Major Adverse Cardiac Event (MACE)
Measured: 6 and 12 months and annually through 5 years follow-up
Stent Thrombosis
Measured: 6 and 12 months and annually through 5 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 20188 Mar 2023

First posted16 Jun 2017
Study start2 Jan 2018
Primary completion17 Jul 2020
Study completion8 Mar 2023

Why it stopped: Company financial insolvency, not due to safety or efficacy concerns

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,630 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03190473
Sponsor's protocol ID: IP-15-001
Acronym: OPTIMIZE
Status last verified: Mar 2023
First submitted: 14 Jun 2017
Last updated: 23 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34353122
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.
PubMed 31415994

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03190473
Acronym / sponsor ID: OPTIMIZE / IP-15-001
Conditions: Acute Coronary Syndrome
Study type: Interventional
Recruitment status: TerminatedReason stopped: Company financial insolvency, not due to safety or efficacy concerns
Enrolment: 1,630 participants (actual)
Lead sponsor: Svelte Medical Systems, Inc.Industry (pharma, biotech, devices)
Study start: 2 Jan 2018 (actual)
Primary completion: 17 Jul 2020 (actual)
Study completion: 8 Mar 2023 (actual)
First posted: 16 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Svelte	Experimental	Device: DES
Control	Active comparator	Device: DES

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (5 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DESPCI with implantation of a DES	Device	Control, Svelte

Primary outcome

Target Lesion Failure (TLF)
Time frame: 12 months

3 secondary outcomes

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

Results and safety

The study was stopped early (reason given: Company financial insolvency, not due to safety or efficacy concerns). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
Derived from this study: PubMed 34353122Kereiakes 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.
Derived from this study: PubMed 31415994Mauri 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.
Individual participant dataSharing planned: No

Related trials for Acute Coronary Syndrome

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shing C Wong, MD study director

Svelte Medical

72 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DES in people with Acute Coronary Syndrome, run by Svelte Medical Systems, Inc. at 72 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Japan, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Company financial insolvency, not due to safety or efficacy concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03190473, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.