Registry of AngioJet Use in the Peripheral Vascular System

Peripheral Vascular Disease Clinical Trial

— PEARLII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086215
• Other study ID #: PEARLII
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: November 3, 2014
• Start date: January 2010
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism and Thrombosis
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Thrombosis
• Vascular Diseases
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	Winnipeg Regional Health Authority	Winnipeg	Manitoba
Germany	Städtisches Klinikum Karlsruhe gGmbH	Karlsruhe
Italy	University of Naples	Naples
Slovakia	National Institute of CV Diseases	Bratislava
United States	St Luke's Hospital & Health Network	Bethlehem	Pennsylvania
United States	Cardiovascular Consultants	Bossier City	Louisiana
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Iowa Health	Des Moines	Iowa
United States	Duke University Medical Center	Durham	North Carolina
United States	Chris Recknor PC	Gainesville	Georgia
United States	Phoenix Heart, PLLC	Glendale	Arizona
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	University of Florida- College of Medicine	Jacksonville	Florida
United States	Holston Valley Medical Center	Kingsport	Tennessee
United States	University of Tennessee - Knoxville	Knoxville	Tennessee
United States	Indiana University Health Arnett	Lafayette	Indiana
United States	Regional Medical Center of Acadiana	Lafayette	Louisiana
United States	Good Samaritan Hospital	Los Angeles	California
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Mount Sinai School of Medicine	New York City	New York
United States	Christiana Care Health System	Newark	Delaware
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	John C. Lincoln Deer Valley Hospital	Phoenix	Arizona
United States	Chilton Memorial Hospital	Pompton Plains	New Jersey
United States	The Miriam Hospital	Providence	Rhode Island
United States	The Reading Hospital & Medical Center	Reading	Pennsylvania
United States	North Central Heart Institute	Sioux Falls	South Dakota
United States	The University of Toledo Medical Center	Toledo	Ohio
United States	Winchester Medical Center	Winchester	Virginia
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No