Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)

PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths

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

Study Overview

• Status: Completed
• Conditions: Embolism and Thrombosis; Venous Thrombosis; Peripheral Vascular Disease

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Winnipeg Regional Health Authority
• Germany
  • Karlsruhe, Germany
    • Städtisches Klinikum Karlsruhe gGmbH
• Italy
  • Naples, Italy
    • University of Naples
• Slovakia
  • Bratislava, Slovakia
    • National Institute of CV Diseases
• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Phoenix Heart, PLLC
    • Phoenix, Arizona, United States, 85029
      • John C. Lincoln Deer Valley Hospital
  • California
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System
  • Florida
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute
    • Jacksonville, Florida, United States, 32209
      • University of Florida- College of Medicine
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Hospital
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Chris Recknor PC
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Indiana University Health Arnett
  • Iowa
    • Des Moines, Iowa, United States, 50263
      • Iowa Health
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Cardiovascular Consultants
    • Houma, Louisiana, United States, 70360
      • Terrebonne General Medical Center
    • Lafayette, Louisiana, United States, 70506
      • Regional Medical Center of Acadiana
  • New Jersey
    • Pompton Plains, New Jersey, United States, 07444
      • Chilton Memorial Hospital
  • New York
    • New York City, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Dayton, Ohio, United States, 45435
      • Good Samaritan Hospital
    • Toledo, Ohio, United States, 43614
      • The University of Toledo Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St Luke's Hospital & Health Network
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Reading, Pennsylvania, United States, 19611
      • The Reading Hospital & Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • University of South Carolina
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart Institute
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Valley Medical Center
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee - Knoxville
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community population

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Limb Ischemia; Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis; Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access; Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions; Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.	From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician.; complete occlusion (>90% occlusion);; substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);; partial occlusion (<50% occlusion AND <3cm in length); patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value.	Day 1
Rethrombosis	The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.	3 Month , 6 Month and 12 Month Follow Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concomitant Treatments Used With the AngioJet® System	The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure	Day 1

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Lawrence Blitz, MD, Chilton Memorial Hospital; Study Director: Robert Lookstein, MD, Icahn School of Medicine at Mount Sinai; Principal Investigator: Ali Amin, MD, The Reading Hospital & Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: March 12, 2010
• First Posted (ESTIMATE): March 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 10, 2014
• Last Update Submitted That Met QC Criteria: November 3, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Embolism; Peripheral Arterial Disease; Peripheral Vascular Diseases; Thrombosis; Venous Thrombosis; Embolism and Thrombosis
• Other Study ID Numbers: PEARLII