INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery (INTeGRATE)

September 8, 2026 updated by: Abiomed Inc.

Initiation and Titration of Guideline Directed Medical Therapy in Heart Failure Cardiogenic Shock With Impella 5.5 for Cardiac Recovery: INTeGRATE

The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, single arm, multi-center, post-market, on-label study. For patients presenting with cardiogenic shock in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis (also known as decompensated heart failure complicated with cardiogenic shock, commonly referred to as heart failure-related cardiogenic shock, HF-CS, including both acute-on-chronic and de novo presentations) as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP), an intentional device-supported strategy with Impella 5.5™ for optimization of guideline-directed medical therapy (GDMT) combined with best practices improves outcomes over standard of care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Roberta Chapman, MD, FACC, FACP, FHFSA
  • Phone Number: +1 978-882-8421
  • Email: rchapm11@its.jnj.com

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
        • Contact:
        • Principal Investigator:
          • Debbie Rinde-Hoffman, MD, FACC, FACP, FHFSA
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension St. Vincent
        • Contact:
        • Principal Investigator:
          • Sunit-Preet Chaudhry, MD, FACC
    • Minnesota
      • Minneapolis, Minnesota, United States, 555407
        • Abbott Northwestern
        • Contact:
        • Principal Investigator:
          • Kasia Hryniewicz, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Barnes Jewish
        • Contact:
        • Principal Investigator:
          • Justin Vader, MD, MPHS
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
        • Principal Investigator:
          • Kanika Mody, MD
        • Contact:
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers-Robert Wood Johnson Medical School
        • Contact:
        • Principal Investigator:
          • Maya Guglin, MD, PhD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Durham, North Carolina, United States, 27710
        • Duke University
        • Contact:
        • Principal Investigator:
          • Adam DeVore, MD, MHS, FHFSA, FAHA, FACC
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • Olivia Gilbert, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
        • Contact:
        • Principal Investigator:
          • Joyce Wald, DO, FACC
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
        • Principal Investigator:
          • Matthew Lander, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian
        • Contact:
        • Principal Investigator:
          • Sideris Facaros, MD
    • Tennessee
      • Nashville, Tennessee, United States, 32703
        • Centennial Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas McRae, MD, FACC
        • Principal Investigator:
          • Zachary J II'Giovine, MD, FACC
    • Texas
      • Dallas, Texas, United States, 75243
        • Medical City Heart Hospital Dallas
        • Contact:
        • Principal Investigator:
          • Song Li, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
        • Principal Investigator:
          • Stavros Drakos, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 and < 80 years
  2. Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form
  3. LVEF ≤ 40%

  4. Subject is presenting with decompensated heart failure and meets at least two (2) of the following cardiogenic shock criteria:

    1. Hypotension (sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for inotropic/vasoactive agents to maintain such blood pressure)
    2. Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate >2 mmol/L)
    3. Cardiac index (CI) < 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
    4. Required support with an intra-aortic balloon pump (IABP) or Impella CP™

  5. Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission, defined as:

    1. On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi)
    2. If on BB and RASi, at least one of the two medications is < 50% of the maximal target dose

Exclusion Criteria:

  1. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:

    1. Drug allergies or hypersensitivities* to HF GDMT medications, unless alternative can be identified

      *Drug allergy/hypersensitivity is an immune-mediated reaction to a medication. Adverse reactions must be a result of immune or inflammatory cell stimulations by the mеԁiсаtion.

    2. Known bilateral renal artery stenosis
    3. Type 1 diabetes
    4. 2o or 3o AV block, unless pacemaker is in place
    5. Angioedema, hereditary or idiopathic
    6. Pregnancy, known or confirmed by a pregnancy test if of childbearing potential
  2. ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment
  3. Septic shock, shock from non-cardiac origins, or mixed shock
  4. SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment
  5. In cardiac arrest prior to enrollment

  6. Prolonged use (or use with complication) of Intra-aortic balloon pump (IABP) or Impella CP™ prior to enrollment, meeting at least one of the following:

    1. IABP use >24 hours if placed at the enrolling site or >48 hours if transferred on IABP
    2. Impella CP™ use >24 hours if placed at the enrolling site or >48 hours if transferred on Impella CP™
    3. Experienced complication(s) from IABP including clinically significant vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion
    4. Experienced complication(s) from Impella CP™ including clinically significant hemolysis, vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion
  7. On mechanical circulatory support other than IABP or Impella CP™ (i.e. ECMO, etc) or on mechanical ventilation for non-procedural reasons prior to enrollment
  8. Revascularization or cardiac surgery within 30-days prior to enrollment
  9. Infiltrative/restrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or myocarditis requiring high-dose immunosuppression
  10. Complex adult congenital heart disease
  11. Primary severe valvular disease
  12. Predominant RV dysfunction per Investigator's discretion
  13. History of heart transplant or listed for heart transplant or planned for heart transplantation prior to enrollment
  14. Planned to be implanted with a permanent VAD within 180-days of the index hospitalization date
  15. Continuous outpatient inotropic support prior to the index hospitalization date
  16. Planned to pursue palliative care or hospice, or life expectancy of less than 1 year due to non-cardiac illness at the time of index hospitalization date
  17. Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 and above), or has nephropathy of hereditary, infectious, or autoimmune origin
  18. Pre-existing functional liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease
  19. Pre-existing pulmonary disease with oxygen dependency
  20. History of stroke or intracranial hemorrhage ≤ 90 days prior to the index hospitalization date, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with modified Rankin Scale (mRS) >2

  21. Any contraindication that precludes placing an Impella 5.5™, including but not limited to:

    1. Aortic valve stenosis/calcification with orifice area ≤ 0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography
    2. Presence of mechanical aortic valve or heart constrictive device
    3. Mural thrombus in the left ventricle
    4. Severe arterial disease precluding placement of Impella
    5. Presence of atrial or ventricular septal defect
    6. Left ventricular rupture
    7. Cardiac tamponade
    8. Combined cardiorespiratory failure
  22. Infection of the planned procedural access site or systemic active infection including sepsis and bacteremia
  23. Intolerance to anticoagulant or antiplatelet therapies, or will refuse blood transfusions
  24. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
  25. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device
  26. Subject belongs to a vulnerable population, such as prisoners, pregnant women, handicapped, mentally disabled persons, or economically or educationally disadvantaged persons per 21CFR56.111(a)(3) and 111(b)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm study
This is a single arm study.
Device: Impella 5.5 SmartAssist
The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)
Time Frame: Timeframe: 180-days post-enrollment
Timeframe: 180-days post-enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite of all-cause death and heart replacement
Time Frame: 90-days, 180-days, 1-year post-enrollment
90-days, 180-days, 1-year post-enrollment
Composite of all-cause death, HF hospitalization, and heart replacement
Time Frame: 90-days, 1-year post-enrollment
90-days, 1-year post-enrollment
All-cause mortality
Time Frame: Hospital Discharge (within 24 hours) , 90-days, 180-days, 1-year post-enrollment
Hospital Discharge (within 24 hours) , 90-days, 180-days, 1-year post-enrollment
Cardiovascular mortality
Time Frame: Hospital Discharge (within 24 hours), 90-days, 180-days, 1-year post-enrollment
Hospital Discharge (within 24 hours), 90-days, 180-days, 1-year post-enrollment
Worsening heart failure
Time Frame: 90-days, 180-days, 1-year post-enrollment
HF hospitalization or urgent HF visit
90-days, 180-days, 1-year post-enrollment
Composite of all-cause death and worsening heart failure
Time Frame: 90-days, 180-days, 1-year post-enrollment
90-days, 180-days, 1-year post-enrollment
Non-HF cardiovascular hospitalization
Time Frame: 90-days, 180-days, 1-year post-enrollment
90-days, 180-days, 1-year post-enrollment
All cardiovascular hospitalization
Time Frame: 90-days, 180-days, 1-year post-enrollment
90-days, 180-days, 1-year post-enrollment
Composite of all-cause death and all cardiovascular hospitalization
Time Frame: 90-days, 180-days, 1-year post-enrollment
90-days, 180-days, 1-year post-enrollment
Rate of major device-related adverse events
Time Frame: Hospital Discharge (within 24 hours), 30-days post-enrollment

The composite rate of any of the following device-related serious adverse events:

  1. Major vascular access site complication
  2. Major hemolysis
  3. Bleeding, defined as MCS-ARC Type 3 or higher
  4. Structural complication requiring repair
  5. Stroke
Hospital Discharge (within 24 hours), 30-days post-enrollment
Subjects achieving indicated GDMT treatment
Time Frame: Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
Achieving any dose of all four classes
Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
% of Subjects achieving optimized GDMT treatment
Time Frame: 90-days and 180-days post-enrollment
Achieving at least 50% of the target dose of all four classes
90-days and 180-days post-enrollment
Modified Heart Failure Collaboratory (mHFC) score
Time Frame: Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
Defined by HFC in 2022. Improvement from baseline
Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
Rate of GDMT-Related Serious Adverse Events
Time Frame: Hospital Discharge (within 24 hours), 90-days, and 180-days post-enrollment

The composite rate of any of the following GDMT-related serious adverse events:

  1. Recurrence or worsening shock; symptomatic hypotension requiring admission
  2. Bradycardia requiring treatment
  3. Hyperkalemia requiring intervention
  4. Ketoacidosis requiring treatment
  5. Need for new renal replacement therapy (RRT)
Hospital Discharge (within 24 hours), 90-days, and 180-days post-enrollment
Quality of life assessed by EQ-5D
Time Frame: 180-days and 1-year post-discharge
improvement from baseline
180-days and 1-year post-discharge
6-Minute Walk Test Distance
Time Frame: 180-days and 1-year post-discharge
improvement from baseline
180-days and 1-year post-discharge
Change in LVEF from baseline
Time Frame: 180-days post-discharge
180-days post-discharge
Change in LVEDD from baseline
Time Frame: 180-days post-discharge
180-days post-discharge
Change in NYHA HF Class from baseline
Time Frame: 180-days post-discharge
180-days post-discharge
Change in HF biomarker
Time Frame: Hospital Discharge (within 24 hours), 30-days, and 90-days post-discharge
NT-proBNP from baseline
Hospital Discharge (within 24 hours), 30-days, and 90-days post-discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
% of Subjects achieving optimized GDMT treatment
Time Frame: Through 1-year post-discharge
Achieving any dose of all four classes and at least 50% of the target dose of β-blocker and RASi
Through 1-year post-discharge
Modified Heart Failure Collaboratory (mHFC) score
Time Frame: Through 1-year post-discharge
Defined by HFC in 2022. Improvement from baseline
Through 1-year post-discharge
Rate of GDMT-Related Serious Adverse Events
Time Frame: Through 1-year post-discharge

The composite rate of any of the following GDMT-related serious adverse events:

  1. Recurrence or worsening shock; symptomatic hypotension requiring admission
  2. Bradycardia requiring treatment
  3. Hyperkalemia requiring intervention
  4. Ketoacidosis requiring treatment
  5. Need for new renal replacement therapy (RRT)
Through 1-year post-discharge
% of Subjects free from heart replacement
Time Frame: Through 1-year post-discharge
Freedom from durable ventricular assist device (VAD) or heart transplant (HTx)
Through 1-year post-discharge
Rate of subjects with HF hospitalization or urgent HF visit
Time Frame: Through 1-year post-discharge
Through 1-year post-discharge
% of Subjects with cardiovascular mortality and all cause mortality
Time Frame: Through 1-year post-discharge
Through 1-year post-discharge
% of Subjects with all-cause death
Time Frame: Through 1-year post-discharge
Through 1-year post-discharge
Left ventricular ejection fraction (LVEF)
Time Frame: Through 1-year post-discharge
Change from baseline
Through 1-year post-discharge
Left ventricular end-diastolic diameter (LVEDD)
Time Frame: Through 1-year post-discharge
Change from baseline
Through 1-year post-discharge
N-Terminal pro b-type natriuretic peptide (NT-proBNP)
Time Frame: Through 1-year post-discharge
Change from baseline
Through 1-year post-discharge
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Through 1-year post-discharge
Improvement from baseline
Through 1-year post-discharge
Quality of life assessed by EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)
Time Frame: Through 1-year post-discharge
Improvement from baseline
Through 1-year post-discharge
6-Minute Walk Test Distance
Time Frame: Through 1-year post-discharge
Improvement from baseline
Through 1-year post-discharge
New York Heart Association (NYHA) heart failure class
Time Frame: Through 1-year post-discharge
Improvement from baseline
Through 1-year post-discharge
Society for Cardiovascular Angiography & Interventions (SCAI) shock stage
Time Frame: Time of device removal
Improvement from baseline
Time of device removal
Rate of major device-related adverse events
Time Frame: Hospital discharge

The composite rate of any of the following device-related serious adverse events:

  1. Major vascular access site complication
  2. Major hemolysis
  3. Bleeding, defined as MCS-ARC Type 3 or higher
  4. Structural complication requiring repair
  5. Stroke
Hospital discharge
GDMT Optimization Change Score
Time Frame: Through 1-year post-discharge
Sum of positive therapy changes (+2 for new GDMT initiations, +1 for dose uptitration) and negative therapy changes (-2 for GDMT discontinuation, -1 for dose downtitration) from baseline
Through 1-year post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abiomed Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johnson & Johnson

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam DeVore, MD, MHS, Duke University
  • Principal Investigator: Gavin Hickey, MD, University of Pittsburgh
  • Principal Investigator: Manreet Kanwar, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INTeGRATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings