Protected PCI Study

July 11, 2016 updated by: Abiomed Inc.

PROTECTED PCI STUDY: A Prospective Clinical Trial For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System

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

Study Overview

Status

Unknown

Conditions

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%.

Study Type

Observational

Enrollment (Anticipated)

369

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 Locations

    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days post index procedure

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: William O'Neill, MD, Henry Ford Hospital

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

November 1, 2015

Primary Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTECT III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Heart Failure

3
Subscribe