A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00778336|
Recruitment Status : Completed
First Posted : October 23, 2008
Results First Posted : April 26, 2011
Last Update Posted : October 17, 2014
|Condition or disease|
|Peripheral Vascular Diseases Thrombosis Venous Thrombosis|
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.
|Study Type :||Observational|
|Actual Enrollment :||452 participants|
|Official Title:||Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions
Patients presenting with thrombosed conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment.
- Change From Baseline to Final Angiographic Results [ Time Frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment) ]
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.
- Rethrombosis [ Time Frame: 3 Month Follow Up ]The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).
- Description of Treatments by Thrombotic Condition [ Time Frame: Index Procedure ]The # of patients that were exposed to each treatment at least once in the given thrombotic condition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778336
|Principal Investigator:||Lawrence R. Blitz, MD||Chilton Memorial Hospital, Pompton Plains, NJ|
|Principal Investigator:||Robert Lookstein, MD||Mount Sinai School of Medicine, NYC, NY|
|Principal Investigator:||Eugene Simoni, MD||Samaritan Vascular Institute, Dayton, OH|