The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.
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
Enrollment
500
Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
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.
Time frame: Day 1
Rethrombosis
The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.
Time frame: 3 Month , 6 Month and 12 Month Follow Up
Concomitant Treatments Used With the AngioJet® System
The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Phoenix Heart, PLLC
Glendale, Arizona, United States
John C. Lincoln Deer Valley Hospital
Phoenix, Arizona, United States
Good Samaritan Hospital
Los Angeles, California, United States
Christiana Care Health System
Newark, Delaware, United States
University of Florida- College of Medicine
Jacksonville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Chris Recknor PC
Gainesville, Georgia, United States
Indiana University Health Arnett
Lafayette, Indiana, United States
Iowa Health
Des Moines, Iowa, United States
...and 26 more locations