A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Thrombosis Clinical Trial

Official title:

Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778336
• Other study ID #: PEARL
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: October 8, 2014
• Start date: January 2007
• Est. completion date: April 2010

Study information

• Verified date: October 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

This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.

Description:

The PEARL Registry collects real world data about mid-length AngioJet catheters to:

• Characterize usage patterns, treatment approaches, and targeted vessels

• Document treatment strategies, including specific techniques and concomitant therapies

• Collect outcome data during initial hospitalization and at a 3-month follow-up phone call or visit

• Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatments provided

• Identify treatment strategies that may optimize procedural and clinical outcomes, to facilitate development of treatment guidelines

• Offer sites a valuable resource for tracking usage and performance of the AngioJet System at their institution

Information collected by the PEARL Registry is intended for educational and clinical research purposes only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient has been treated with a mid-length AngioJet catheter(defined as 90-120 cm in length)

• Patient has provided appropriate authorization per institutional policy and procedure.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Final Angiographic Results	From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,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 value from the final value.	Index Procedure ( pre-endovascular treatment and post-endovascular treatment)	No
Secondary	Rethrombosis	The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).	3 Month Follow Up	No
Secondary	Description of Treatments by Thrombotic Condition	The # of patients that were exposed to each treatment at least once in the given thrombotic condition.	Index Procedure	No