Clinical trial NCT00534859: PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
Official title: PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients Undergoing High Risk PCI.
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
* EF \<35%

Exclusion Criteria:

* ST Myocardial Infarction
* Cardiac Arrest
* Cardiogenic Shock
* Thrombus Left Ventricle

Primary outcomes:
measure: MACCE Events at 30 days or discharge, whichever is longer
timeFrame: 30 days or discharge
measure: Freedom from Hemodynamic compromise during PCI procedure
timeFrame: During procedure
Secondary outcomes:
measure: Other intra-procedural and peri-procedural adverse events
timeFrame: During treatment and out to 90 days
measure: Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion
timeFrame: During procedure
measure: Angiographic Success
timeFrame: Post-PCI
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Womens
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont
state: Michigan
city: New York,
country: United States
facility: Columbia Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Texas Heart
state: Texas
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Netherland
Study officials:
affiliation: Not affiliated with Abiomed
name: William O'Neill, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005.