Registry of AngioJet Use in the Peripheral Vascular System

Completed

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

• Registration Number: NCT01086215
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Results First Submitted: 2014-10-29
• Results First Submitted QC: 2014-10-29
• Status Verified: 2014-11
• Results First Posted: 2014-11-02
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rethrombosis	3 Month , 6 Month and 12 Month Follow Up	The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.
Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.	Day 1	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.; 1. complete occlusion (\>90% occlusion); 2. substantial occlusion (50-90% occlusion OR \<50% occlusion and \>3cm in length); 3. partial occlusion (\<50% occlusion AND \<3cm in length); 4. 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.

Secondary Outcome Measures

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

Trial Locations

Locations (35)

Phoenix Heart, PLLC; 🇺🇸 Glendale, Arizona, United States

John C. Lincoln Deer Valley Hospital; 🇺🇸 Phoenix, Arizona, United States

Good Samaritan Hospital; 🇺🇸 Dayton, Ohio, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States

University of Florida- College of Medicine; 🇺🇸 Jacksonville, Florida, United States

First Coast Cardiovascular Institute; 🇺🇸 Jacksonville, Florida, United States

Sacred Heart Hospital; 🇺🇸 Pensacola, Florida, United States

Chris Recknor PC; 🇺🇸 Gainesville, Georgia, United States

Indiana University Health Arnett; 🇺🇸 Lafayette, Indiana, United States

Iowa Health; 🇺🇸 Des Moines, Iowa, United States

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