Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The OPTIMAL Randomized Controlled Trial (OPTIMAL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111770
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : December 6, 2019
Sponsor:
Collaborators:
Philips Healthcare
Boston Scientific Corporation
Information provided by (Responsible Party):
ECRI bv

Brief Summary:

The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided Percutaneous Coronary Intervention (PCI). Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure.

Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and 24 months (outpatient clinic visit or telephone call) after the index procedure.


Condition or disease Intervention/treatment Phase
Left Main Coronary Artery Stenosis Device: IVUS guided Percutaneous Coronary Intervention Device: QCA guided Percutaneous Coronary Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: IVUS guided PCI
Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
Device: IVUS guided Percutaneous Coronary Intervention
Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.

Active Comparator: QCA guided PCI
QCA will be used to determine lesion characteristics
Device: QCA guided Percutaneous Coronary Intervention
QCA will be used to determine lesion characteristics




Primary Outcome Measures :
  1. Patient-oriented Composite Endpoint (POCE) [ Time Frame: 2 years follow up ]
    Patient-oriented Composite Endpoint (PoCE): composite of all-cause death, any stroke, any myocardial infarction (MI)*, any clinically indicated revascularization at 2 years follow-up.


Secondary Outcome Measures :
  1. Device-oriented Composite Endpoint (DoCE) [ Time Frame: 1 and 2 years follow up ]
    Device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel MI, clinically indicated repeat revascularization of the target lesion at 1 and 2 years.

  2. Vessel-oriented Composite Endpoint (VoCE) [ Time Frame: 1 and 2 years follow up ]
    Vessel-oriented Composite Endpoint (VoCE) defined as the composite of: left main related cardiac death, target vessel MI, clinically indicated -repeat revascularization of the left main vessels at 1 and 2 years.

  3. Patient-oriented Composite Endpoint (POCE) [ Time Frame: 1 year follow up ]
    Patient-oriented Composite Endpoint (PoCE): composite of all-cause death, any stroke, any myocardial infarction (MI)*, any clinically indicated revascularization at 2 years follow-up.

  4. All individual components of PoCE at all time points. [ Time Frame: 1 and 2 years follow up ]
    All individual components of PoCE at all time points.

  5. All individual components of DoCE at all time points. [ Time Frame: 1 and 2 years follow up ]
    All individual components of DoCE at all time points.

  6. Definite and probable stent thrombosis [ Time Frame: 1 and 2 years ]
    Definite and probable stent thrombosis according to ARC definition

  7. Hospitalization for heart failure [ Time Frame: 2 years ]
    Investigator reported hospitalization for heart failure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must be ≥ 18 years of age;
  2. De novo lesion of the LM (ostial, shaft or distal) where PCI is considered appropriate and feasible by the Heart Team*.
  3. Stable or unstable angina, non-ST segment myocardial infarction, documented silent ischemia or a positive functional study (e.g. by pressure or angiography derived indices).
  4. Any left-main Medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included.
  5. A patient with a previous coronary artery bypass graft (CABG) with no patent bypass on the LCA may be included.
  6. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.

Exclusion Criteria:

  1. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential).
  2. Ongoing MI or recent MI with cardiac biomarker levels still elevated.
  3. Previous history of CABG with patent Left Internal Mammary Artery (LIMA) to LAD and/or patent graft to the left circumflex coronary.
  4. Prior PCI of the left-main or the ostium of the LAD or the ostium of the LCX at any time prior to enrolment.
  5. Prior PCI in LCA (e.g. mid LAD) within the previous 30 days.
  6. Known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (DAPT) duration
  7. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization.
  8. Non-cardiac co-morbidities with a life expectancy less than 2 years.
  9. Currently participating in another trial and not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study for at least 12 months after enrolment.

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): NCT04111770


Contacts
Layout table for location contacts
Contact: Ron van Amsterdam, PhD, DipPharMed +31 (0)10 206 28 00 rvamsterdam@cardialysis.nl

Locations
Layout table for location information
Italy
ITA-001
Milan, Italy
United Kingdom
UNK-001
Oxford, United Kingdom
Sponsors and Collaborators
ECRI bv
Philips Healthcare
Boston Scientific Corporation
Investigators
Layout table for investigator information
Principal Investigator: Adrian Banning, Prof Oxford University Hospitals NHS Trust
Principal Investigator: Luca Testa, Dr. Policlinco San Donato
Layout table for additonal information
Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT04111770    
Other Study ID Numbers: ECRI-013
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by ECRI bv:
IVUS
PCI
Left Main
QCA
Treatment Strategy
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases