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

Abiomed Inc.1 site in 1 country369 target enrollmentNovember 2015

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
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.
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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%.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

November 2020

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abiomed Inc.

Responsible Party

Sponsor

Eligibility Criteria

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