Protected PCI Study

NCT02831881 | Unknown DMC

• 1 other identifier: PROTECT III
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• A composite rate of the following intra-procedural and post-procedural major adverse events (MAE) at 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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:

• \. 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

Sponsors & Collaborators

• Abiomed Inc.: lead
• Baim Institute for Clinical Research: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• William O'Neill, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioana Ghiu, MD

CONTACT

ighiu@abiomed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 13, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2020
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (1)