Clinical trial NCT01086215: Registry of AngioJet Use in the Peripheral Vascular System
Official title: PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Disease
Embolism and Thrombosis
Venous Thrombosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community population

Brief summary: The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.

Detailed description: The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months.

A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

Eligibility criteria: Inclusion Criteria:

* Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
* Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.

Exclusion Criteria:

* Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.

Primary outcomes:
measure: Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
timeFrame: Day 1
measure: Rethrombosis
timeFrame: 3 Month , 6 Month and 12 Month Follow Up
Secondary outcomes:
measure: Concomitant Treatments Used With the AngioJet® System
timeFrame: Day 1
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Phoenix Heart, PLLC
state: Arizona
city: Phoenix
country: United States
facility: John C. Lincoln Deer Valley Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Jacksonville
country: United States
facility: University of Florida- College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Gainesville
country: United States
facility: Chris Recknor PC
state: Georgia
city: Lafayette
country: United States
facility: Indiana University Health Arnett
state: Indiana
city: Des Moines
country: United States
facility: Iowa Health
state: Iowa
city: Bossier City
country: United States
facility: Cardiovascular Consultants
state: Louisiana
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: Lafayette
country: United States
facility: Regional Medical Center of Acadiana
state: Louisiana
city: Pompton Plains
country: United States
facility: Chilton Memorial Hospital
state: New Jersey
city: New York City
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Dayton
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo Medical Center
state: Ohio
city: Bethlehem
country: United States
facility: St Luke's Hospital & Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Reading
country: United States
facility: The Reading Hospital & Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Kingsport
country: United States
facility: Holston Valley Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee - Knoxville
state: Tennessee
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority
state: Manitoba
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH
city: Naples
country: Italy
facility: University of Naples
city: Bratislava
country: Slovakia
facility: National Institute of CV Diseases
Study officials:
affiliation: Chilton Memorial Hospital
name: Lawrence Blitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Robert Lookstein, MD
role: STUDY_DIRECTOR
affiliation: The Reading Hospital & Medical Center
name: Ali Amin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.