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Completed

NCT Number: NCT01086215

Registry of AngioJet Use in the Peripheral Vascular System

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

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Embolism and Thrombosis Peripheral Vascular Diseases Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Winnipeg Regional Health Authority, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.

    Time frame: 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.

    • 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.

  2. Rethrombosis

    Time frame: 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.

Secondary outcomes

  1. Concomitant Treatments Used With the AngioJet® System

    Time frame: Day 1

    The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: PEARLII

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2010
Registry last updated
Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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