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Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01086215
First received: January 20, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition
Peripheral Vascular Disease
Embolism and Thrombosis
Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

    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.

  • Rethrombosis [ Time Frame: 3 Month , 6 Month and 12 Month Follow Up ] [ Designated as safety issue: No ]
    The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.


Secondary Outcome Measures:
  • Concomitant Treatments Used With the AngioJet® System [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure


Enrollment: 500
Study Start Date: January 2010
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Limb Ischemia
Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access
Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community population

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086215

  Show 36 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Lawrence Blitz, MD Chilton Memorial Hospital
Study Director: Robert Lookstein, MD Mount Sinai School of Medicine
Principal Investigator: Ali Amin, MD The Reading Hospital & Medical Center
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01086215     History of Changes
Other Study ID Numbers: PEARLII
Study First Received: January 20, 2010
Results First Received: October 29, 2014
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Embolism and Thrombosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Thrombosis
Vascular Diseases
Venous Thromboembolism
Venous Thrombosis
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on November 27, 2014