Status:
UNKNOWN
Protected PCI Study
Lead Sponsor:
Abiomed Inc.
Collaborating Sponsors:
Baim Institute for Clinical Research
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Brief Summary
A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients.
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT02831881
Start Date
November 1 2015
Last Update
July 13 2016
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202