NCT02831881UnknownNot Applicable
PROTECTED PCI STUDY: A Prospective Clinical Trial For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Abiomed Inc.
- Enrollment
- 369
- Locations
- 1
- Primary Endpoint
- A composite rate of the following intra-procedural and post-procedural major adverse events (MAE) at 90 days post index procedure.
Study Overview
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. 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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