Protected PCI Study

Status unconfirmed

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID: NCT02831881
Run by: Abiomed Inc.
People needed: 369
Starts: 2015-11-01
Last updated by the study team: 2016-07-13

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed Informed Consent
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
Age eligible (18 ≤ Age ≤ 90)
Subject presents with:
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
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.

You may not qualify if…

1. ST Myocardial Infarction within 24 hours or CK-MB that have not normalized
Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR
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)
Mural thrombus in the left ventricle
Patient scheduled for revascularization of a total chronic occlusion (CTO) or transcatheter aortic valve replacement within 1 year of index procedure.
The presence of a mechanical aortic valve or heart constrictive device
Documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less.
Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2)
Severe peripheral arterial obstructive disease that would preclude the IMPELLA System device placement
Abnormalities of the aorta that would preclude surgery, including aneurysms and extreme tortuosity or calcifications
Subject with renal failure (creatinine ≥ 4mg/dL or on dialysis)
Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥ 2
Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.0.)
History of recent (within 1 month) stroke or TIA
Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors(clopidogrel and ticlid) or contrast media
Subject with documented heparin induced thrombocytopenia
Participation in the active follow-up phase of another clinical study of an investigational drug or device

Where it is running

Henry Ford Hospital — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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