A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
- Conditions
- Venous ThrombosisThrombosisPeripheral Vascular Diseases
- Registration Number
- NCT00778336
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
- Patient has been treated with a mid-length AngioJet catheter(defined as 90-120 cm in length)
- Patient has provided appropriate authorization per institutional policy and procedure.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline to Final Angiographic Results 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:
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 value from the final value.
- Secondary Outcome Measures
Name Time Method Rethrombosis 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 Index Procedure The # of patients that were exposed to each treatment at least once in the given thrombotic condition.