A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
This study has been completed.
Sponsor:
MEDRAD, Inc.
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT00778336
First received: October 22, 2008
Last updated: July 9, 2012
Last verified: July 2012
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Purpose
This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.
| Condition |
|---|
|
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 |
Resource links provided by NLM:
Further study details as provided by MEDRAD, Inc.:
Primary Outcome Measures:
- Change From Baseline to Final Angiographic Results [ Time Frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment) ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Rethrombosis [ Time Frame: 3 Month Follow Up ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The # of patients that were exposed to each treatment at least once in the given thrombotic condition.
| 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 |
|---|
|
Limb Ischemia
Patients presenting with limb ischemia for treatment
|
|
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
|
|
Hemodialysis Access
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778336
Sponsors and Collaborators
MEDRAD, Inc.
Investigators
| 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
No publications provided
| Responsible Party: | MEDRAD, Inc. |
| 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: | July 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by MEDRAD, Inc.:
|
Peripheral Thrombosis DVT Limb Ischemia |
AV Access AngioJet Thrombectomy |
Additional relevant MeSH terms:
|
Thrombosis Vascular Diseases Venous Thrombosis Venous Thromboembolism Peripheral Vascular Diseases Peripheral Arterial Disease |
Embolism and Thrombosis Cardiovascular Diseases Thromboembolism Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 21, 2013