Coronary Artery DiseaseNCT04648306
Restore EF Observational Study
An observational study of Coronary Artery Disease and Unstable Angina, run by Abiomed Inc. at 21 sites in United States.
Trial summary
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Unstable Angina, Angina, Stable
- What is being tested?
- Prophylactic Impella support for a non-emergent PCI
- Type of treatment
- Medical device
- How many people
- 406 participants
- Where
- 21 sitesUnited States
- Study dates
- 1 Sep 2019to 30 Sep 2021
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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
Study population: Patients who meet all the inclusion criteria and none of the exclusion criteria will be enrolled in the study. Patients in whom prophylactic hemodynamic support with Impella was used during a non-emergent PCI will be evaluated for study participation at 60 days post index PCI procedure with Impella. In this study the index procedure is designated as Impella Protected PCI (ProPCI). Patients with cardiogenic shock and/or ST elevation myocardial infarction (STEMI) at the time of Impella initiation will not be included in this study.
Who may be able to join
- Age ≥ 18 years
- Subject has previously undergone (≥ 60 days) an Impella Protected PCI (ProPCI) at a study site as identified in the Impella quality (IQ) assurance database (patients who expired or were lost to follow-up prior to opening of the follow-up study window (day 60 post Impella protected PCI) will not be included in the study
Who cannot join
- Subject with cardiogenic shock at the time of Impella insertion. Cardiogenic shock defined as: systemic hypotension (systolic blood pressure (SBP) <90 mmHg or the need for inotropes/pressors to maintain a SBP >90mmHg)
- Subject with ST elevation myocardial infarction at the time of Impella insertion.
- Subject underwent coronary bypass surgery after the index Impella ProPCI
- Subject underwent repeat revascularization with PCI after the index Impella ProPCI
- Subject underwent other cardiac procedures including valve therapies (surgical or percutaneous) after the index Impella ProPCI
- Subject underwent cardiac resynchronization therapy (CRT) initiated after the index Impella ProPCI
- Any known medical condition with a life expectancy <6 months
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Presbyterian Hospital Dallas
Arlington, Texas, 76011
Christ Hospital
Cincinnati, Ohio, 45219
Mercy Hospital
Coon Rapids, Minnesota, 55433
Genesis Medical Center
Davenport, Iowa, 52803
Advent Health
Daytona Beach, Florida, 32117
Washington Regional Medical Center
Fayetteville, Arkansas, 72703
Vidant Medical Center
Greenville, North Carolina, 28275
Lafayette General Medical Center
Houma, Louisiana, 70360
Kingwood Medical Center
Kingwood, Texas, 77339
Baptist Healthcare System
Lexington, Kentucky, 40503
Loma Linda University Medical
Loma Linda, California, 92354
NYU Langone Medical Center
New York, New York, 10016
Sentara Healthcare
Norfolk, Virginia, 23507
Arkansas Cardiology P.A.
North Little Rock, Arkansas, 72117
St. Joseph's Medical Center
Phoenix, Arizona, 85016
Providence Portland Medical Center
Portland, Oregon, 97213
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
UCSD Medical Center
San Diego, California, 92093
NorthShore University HealthSystem
Skokie, Illinois, 60076
Northwest Medical Center
Springdale, Arkansas, 72764
Tucson Medical Center
Tucson, Arizona, 85719
About this study
Official title: Restore EF Observational Study (in High-risk PCI)
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).
Read the detailed description
- Hypothesis The prophylactic use of Impella 2.5 or CP heart pumps during a non-emergent PCI in hemodynamically stable patients at high-risk for periprocedural complications during the procedure is associated with a significant improvement in the patient's LVEF and clinical status (heart failure symptoms and hospital readmissions) in the intermediate-term follow-up period post-ProPCI
- Objectives The primary objective of this study is to assess the patient's LVEF at 90 days post-ProPCI (60 to 180 days window) as assessed in routine clinical practice and collected from EHR by clinical investigators. The secondary objective of the study is to assess the potential association between the completeness of revascularization and the clinical status at 90 days post-ProPCI (60-180 days window). Clinical status includes NYHA heart failure functional class and hospital readmission.
- Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases).
- Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR.
- Secondary Endpoints:
- Completeness and extent of revascularization
- NYHA functional class at 90 days post-ProPCI (60 to 180 days window)
- Readmission at 90 days post-ProPCI (60 to 180 days window)
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Being tested
- Prophylactic Impella support for a non-emergent PCI
- Keywords
- Impella, Hemodynamic Mechanical Support, Left ventricular ejection fraction, Surgical turndown, High Risk PCI
- Medical subject headings
- Coronary Artery Disease, Angina, Unstable, Angina, Stable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Impella support for a non-emergent PCIDevice
Impella percutaneous mechanical circulatory support is placed via the femoral or axillary artery prior to a non-emergent PCI in patients at high risk for periprocedural complications including hemodynamic collapse.
| Study group | Role | What they receive |
|---|---|---|
| Impella cohort | Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support Receives: Device: Prophylactic Impella support for a non-emergent PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) %
Measured: 90 days post Protective PCI (60 to 180 days window)
Secondary outcomes (3)
Survival Rate
Survival rate post non-emergent percutaneous coronary intervention (ProPCI)
Measured: 90 days post Protected PCI (60 to 180 days window)
NYHA Functional Class
New York Heart Association (NYHA) functional class
Measured: 90 days post Protected PCI (60 to 180 days window)
Readmission
Readmission post non-emergent percutaneous coronary intervention (ProPCI)
Measured: 90 days post Protected PCI (60 to 180 days window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Sep 2019
- Primary completion31 May 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thom Dahle, MD, Study chair, Saint Cloud HospitalJason Wollmuth, MD, Study chair, Providence Health & ServicesLynn Morris, MD, Study chair, East Carolina UniversityCraig Thompson, MD, Study chair, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648306
- Sponsor's protocol ID
- V1-07012019
- Status last verified
- Dec 2020
- First submitted
- 17 Nov 2020
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restore EF Observational Study (in High-risk PCI)
- ClinicalTrials.gov ID
- NCT04648306
- Acronym / sponsor ID
- V1-07012019
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Keywords
- Impella, Hemodynamic Mechanical Support, Left ventricular ejection fraction, Surgical turndown, High Risk PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 1 Dec 2020 (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.
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).
Detailed description
- Hypothesis The prophylactic use of Impella 2.5 or CP heart pumps during a non-emergent PCI in hemodynamically stable patients at high-risk for periprocedural complications during the procedure is associated with a significant improvement in the patient's LVEF and clinical status (heart failure symptoms and hospital readmissions) in the intermediate-term follow-up period post-ProPCI
- Objectives The primary objective of this study is to assess the patient's LVEF at 90 days post-ProPCI (60 to 180 days window) as assessed in routine clinical practice and collected from EHR by clinical investigators. The secondary objective of the study is to assess the potential association between the completeness of revascularization and the clinical status at 90 days post-ProPCI (60-180 days window). Clinical status includes NYHA heart failure functional class and hospital readmission.
- Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases).
- Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR.
- Secondary Endpoints:
- Completeness and extent of revascularization
- NYHA functional class at 90 days post-ProPCI (60 to 180 days window)
- Readmission at 90 days post-ProPCI (60 to 180 days window)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impella cohort | – | Device: Prophylactic Impella support for a non-emergent PCISingle arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet all the inclusion criteria and none of the exclusion criteria will be enrolled in the study. Patients in whom prophylactic hemodynamic support with Impella was used during a non-emergent PCI will be evaluated for study participation at 60 days post index PCI procedure with Impella. In this study the index procedure is designated as Impella Protected PCI (ProPCI). Patients with cardiogenic shock and/or ST elevation myocardial infarction (STEMI) at the time of Impella initiation will not be included in this study.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Subject has previously undergone (≥ 60 days) an Impella Protected PCI (ProPCI) at a study site as identified in the Impella quality (IQ) assurance database (patients who expired or were lost to follow-up prior to opening of the follow-up study window (day 60 post Impella protected PCI) will not be included in the study
Key exclusion criteria (7 listed)
- Subject with cardiogenic shock at the time of Impella insertion. Cardiogenic shock defined as: systemic hypotension (systolic blood pressure (SBP) <90 mmHg or the need for inotropes/pressors to maintain a SBP >90mmHg)
- Subject with ST elevation myocardial infarction at the time of Impella insertion.
- Subject underwent coronary bypass surgery after the index Impella ProPCI
- Subject underwent repeat revascularization with PCI after the index Impella ProPCI
- Subject underwent other cardiac procedures including valve therapies (surgical or percutaneous) after the index Impella ProPCI
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 |
|---|---|---|
| Prophylactic Impella support for a non-emergent PCIImpella percutaneous mechanical circulatory support is placed via the femoral or axillary artery prior to a non-emergent PCI in patients at high risk for periprocedural complications including hemodynamic collapse. | Device | Impella cohort |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: 90 days post Protective PCI (60 to 180 days window)
Left ventricular ejection fraction (LVEF) %
3 secondary outcomes
Survival Rate
Time frame: 90 days post Protected PCI (60 to 180 days window)
NYHA Functional Class
Time frame: 90 days post Protected PCI (60 to 180 days window)
Readmission
Time frame: 90 days post Protected PCI (60 to 180 days window)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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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.
Thom Dahle, MD study chair
Saint Cloud Hospital
Jason Wollmuth, MD study chair
Providence Health & Services
Lynn Morris, MD study chair
East Carolina University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Unstable Angina, run by Abiomed Inc. at 21 sites in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left ventricular ejection fraction (LVEF) (time frame: 90 days post Protective PCI (60 to 180 days window)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2021.