Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)
|ClinicalTrials.gov Identifier: NCT01086215|
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : November 2, 2014
Last Update Posted : November 10, 2014
|Condition or disease|
|Peripheral Vascular Disease Embolism and Thrombosis Venous Thrombosis|
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.
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||September 2013|
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 a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086215
|Principal Investigator:||Lawrence Blitz, MD||Chilton Memorial Hospital|
|Study Director:||Robert Lookstein, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Ali Amin, MD||The Reading Hospital & Medical Center|