Protect II, A Prospective, Multicenter Randomized Controlled Trial - Full Text View

Sponsor:	Abiomed Inc.
Information provided by:	Abiomed Inc.
ClinicalTrials.gov Identifier:	NCT00562016

Purpose

The IMPELLA LP 2.5 system will be superior to the intra aortic balloon pump in preventing the composite rare on intra and post procedural major adverse events.

Condition	Intervention
Coronary Artery Disease	Device: IMPLELLA LP 2.5

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	PROTECT II: A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP)in Patients Undergoing Non Emergent High Risk PCI

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:

Composite rate of intra porcedural and post procedural major events. Death, MI,Stroke,TIA, TVR, CABG, Acute renal failure, severe hypotension, CPR Vent Arrythmia requiring, failure angiographic success. [ Time Frame: 30 days ]

Secondary Outcome Measures:

Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. [ Time Frame: In hospital events ]

Estimated Enrollment:	654
Study Start Date:	October 2007

Arms	Assigned Interventions
IMPELLA LP 2.5: Experimental	Device: IMPLELLA LP 2.5 Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood fromthe left ventricle into the asending aorta at 2.5 L/min.
2: Active Comparator	Device: IMPLELLA LP 2.5 Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood fromthe left ventricle into the asending aorta at 2.5 L/min.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent
Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.
Patient presents with:
- A compromise Ejection Fraction
- Intervention on the last patent coronary conduit
- Intervention on an unprotected left main artery or
- Patient presenting with triple vessel disease.

Exclusion Criteria:

ST elevation M.I.
Pre procedure cardiac arrest within 24 hours.
Subject in cardiogenic shock

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562016

Contacts

Contact: Ioana Ghiu	978-239-8734	ighiu@abiomed.com
Contact: Karim Benali	978-646-1800	kbenali@abiomed.com

Locations

United States, Alabama
University of Alabama	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Glenda Cureton, RN 205-975-9426 gcureton@cardmail.dom.uab.edu
United States, Indiana
St. Francis Hospital & Health Centers	Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Kathy Lawson, RN 317-851-2582
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Shawnee Mission	Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Millie Salkind, APRN, BC 913-671-6509
United States, Kentucky
Kentucky Heart Institute Kings Daughters Medical Center	Recruiting
Ashland, Kentucky, United States, 41101
Contact: Susan Slack, RN 606-324-1544
Lourdes Hospital	Recruiting
Paducah, Kentucky, United States, 42003
Contact: Zandra Farley, RN 270-538-5832
United States, Massachusetts
St. Elizabeths Medical Center	Recruiting
Boston, Massachusetts, United States, 02135
Contact: Amy Miller, RN 617-789-7868
Beth Israel	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Theresa Bishoop, RN 617-632-7486
United States, Michigan
William Beaumont	Recruiting
Royal Oak, Michigan, United States
Contact: Jim Wegner 248-898-3123 jwegnr@beaumont.edu
Principal Investigator: Simon Dixon, MD
Providence Hospital and Medical Centers	Recruiting
Southfield, Michigan, United States, 48075
Contact: Nicole Zakhem, RN, BSN 248-849-5328
Northern Michigan	Recruiting
Petoskey, Michigan, United States, 49770
Contact: Jennifer LaLonde, BSN, CCRC 231-487-9185
Oakwood Hospital Wayne State University	Recruiting
Dearborn, Michigan, United States, 48124
Contact: Mary Akagi 313-577-5161
United States, New York
Strong Memorial Hospital	Recruiting
Rochester, New York, United States, 14642
Contact: Valerie Chiodo 585-275-8872
Cornell, Weill Medical Center	Recruiting
New York, New York, United States, 10021
Contact: Dolores Reynolds 212-746-4617
Mt. Sinai School of Medicine	Recruiting
New York, New York, United States, 10029-6574
Contact: Michael Fusilero, MD 212-241-0229
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Luba Mazanec, RN 614-247-7733
Christ Hospital	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Darlene Rock, RN 513-585-1766
United States, Pennsylvania
Pinnacle Health	Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Anita Todd 717-731-0101 ext 3002
UPMC Presbyterian Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Debbie Rosenfelder, RN 412-647-3611
Lankenau Main Line Health Heart Center	Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Lynn Sher 610-645-8581
York Hospital	Recruiting
York, Pennsylvania, United States, 17403
Contact: Barbara Delio-Cox, RN MSN 717-851-3472
United States, Texas
Texas Heart Institute	Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer LaBleu 832-355-6594
TexSan Heart Hospital	Recruiting
San Antonio, Texas, United States, 78229
Contact: Jodie Addington, RN, BA 210-692-1414
Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Xinghony Leng, MD PhD 731-441-3877

Sponsors and Collaborators

Abiomed Inc.

Investigators

Principal Investigator:

William O'Neill

Not affilicated with Abiomed

More Information

No publications provided

Study ID Numbers:	7182007
Study First Received:	November 19, 2007
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00562016 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abiomed Inc.:

Patient undergoing scheduled PCI

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 09, 2010