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| Sponsor: | MEDRAD Interventional/Possis |
|---|---|
| Information provided by: | MEDRAD Interventional/Possis |
| ClinicalTrials.gov Identifier: | NCT00778336 |
Purpose
This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.
| Condition |
|---|
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Peripheral Vascular Diseases Thrombosis Venous Thrombosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters |
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:
The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value.
| Enrollment: | 452 |
| Study Start Date: | January 2007 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Limb Ischemia
Patients presenting with limb ischemia for treatment
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Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
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Hemodialysis Access
Patients presenting with thrombosed hemodialysis access for treatment
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Other Thrombotic Conditions
Patients presenting with thrombosed conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment.
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The PEARL Registry collects real world data about mid-length AngioJet catheters to:
Information collected by the PEARL Registry is intended for educational and clinical research purposes only.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | DeeAnn Tinjum / Sr. Clinical Research Manager, Possis Medical |
| ClinicalTrials.gov Identifier: | NCT00778336 History of Changes |
| Other Study ID Numbers: | PEARL |
| Study First Received: | October 22, 2008 |
| Results First Received: | February 22, 2011 |
| Last Updated: | April 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Peripheral Thrombosis DVT Limb Ischemia |
AV Access AngioJet Thrombectomy |
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Thrombosis Vascular Diseases Venous Thrombosis Peripheral Vascular Diseases Peripheral Arterial Disease |
Embolism and Thrombosis Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |