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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00778336
Other study ID # PEARL
Secondary ID
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


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
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