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Protected PCI Study

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: NCT02831881
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
Baim Institute for Clinical Research
Information provided by (Responsible Party):
Abiomed Inc.

Brief Summary:
A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients.

Condition or disease
Heart Failure

Detailed Description:
The objective of the study is to assess the safety and efficacy of the IMPELLA® 2.5 System in subjects undergoing non-emergent high-risk percutaneous coronary intervention (PCI) post market approval. The primary endpoint will be a composite clinical endpoint of major adverse events through 90 days following the PCI procedure. The outcome will be compared to the pre specified performance goal of 53%.

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Study Type : Observational
Estimated Enrollment : 369 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROTECTED PCI STUDY: A Prospective Clinical Trial For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System
Study Start Date : November 2015
Estimated Primary Completion Date : November 2020



Primary Outcome Measures :
  1. A composite rate of the following intra-procedural and post-procedural major adverse events (MAE) at 90 days post index procedure. [ Time Frame: 90 days post index procedure ]
    The primary endpoint is defined as a composite rate of the major adverse events at 90 days post index procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of high risk subjects indicated for nonemergent percutaneous treatment after heart team evaluation including a cardiac surgeon of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft.
Criteria

Inclusion Criteria:

  1. Signed Informed Consent
  2. Subject is indicated for a NON emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft per the judgement of a heart team including a surgeon
  3. Age eligible (18 ≤ Age ≤ 90)
  4. Subject presents with:

    1. Ejection Fraction≤ 35% AND at least one of the following criteria:

      Intervention on the last patent coronary conduit, or Intervention on an unprotected left main coronary artery Or

    2. Ejection Fraction ≤ 30% and intervention in patient presenting with triple vessel disease. *three-vessel or triple vessel disease is defined as at least one significant stenosis* in all three major epicardial territories: Left Anterior Descending (LAD) Artery and/or side branch, left circumflex (LCX) artery and/or side branch, Right Coronary Artery (RCA) and or side branch. *Significant stenosis is defined as at least 50% diameter stenosis by visual estimate or any total occlusion. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCX qualifies as three-vessel disease.

Exclusion Criteria:

  • 1. ST Myocardial Infarction within 24 hours or CK-MB that have not normalized

    2. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR

    3. Subject is inotrope dependent or in cardiogenic shock defined as: Hypotension (systolic BP < 90 mmHg for > 30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR a urine output of < 30 ml/hour)

    4. Mural thrombus in the left ventricle

    5. Patient scheduled for revascularization of a total chronic occlusion (CTO) or transcatheter aortic valve replacement within 1 year of index procedure.

    6. The presence of a mechanical aortic valve or heart constrictive device

    7. Documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less.

    8. Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2)

    9. Severe peripheral arterial obstructive disease that would preclude the IMPELLA System device placement

    10. Abnormalities of the aorta that would preclude surgery, including aneurysms and extreme tortuosity or calcifications

    11. Subject with renal failure (creatinine ≥ 4mg/dL or on dialysis)

    12. Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥ 2

    13. Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.0.)

    14. History of recent (within 1 month) stroke or TIA

    15. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors(clopidogrel and ticlid) or contrast media

    16. Subject with documented heparin induced thrombocytopenia

    17. Participation in the active follow-up phase of another clinical study of an investigational drug or device


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): NCT02831881


Contacts
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Contact: Ioana Ghiu, MD ighiu@abiomed.com

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Abiomed Inc.
Baim Institute for Clinical Research
Investigators
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Principal Investigator: William O'Neill, MD Henry Ford Hospital

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Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT02831881    
Other Study ID Numbers: PROTECT III
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases