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This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Final Angiographic Results | 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. | Index Procedure ( pre-endovascular treatment and post-endovascular treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Rethrombosis | The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure). | 3 Month Follow Up |
| Description of Treatments by Thrombotic Condition |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
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Patients presenting at a participating site who were clinically indicated for a peripheral interventional(venous or arterial) procedure with the mid-length (90cm or 120cm catheters) catheter were offered the opportunity to participate. Patients were recruited from January 2007 thru December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Limb Ischemia | Patients with limb ischemia treated with a midlength AngioJet catheter. |
| FG001 | Deep Vein Thrombosis | Patients with deep vein thrombosis treated with a midlength AngioJet catheter. |
| FG002 | Hemodialysis Access | Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter. |
| FG003 | Other Thrombotic Conditions | Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Index Procedure-Discharge |
|
| ||||||||||||||||||
| 3 Month Follow Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Limb Ischemia | Patients with limb ischemia treated with a midlength AngioJet catheter. |
| BG001 | Deep Vein Thrombosis | Patients with deep vein thrombosis treated with a midlength AngioJet catheter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Final Angiographic Results | 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. | Intention to Treat (ITT) | Posted | Mean | Standard Error | Occlusion Index | Index Procedure ( pre-endovascular treatment and post-endovascular treatment) |
|
Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Limb Ischemia | Patients with limb ischemia treated with a midlength AngioJet catheter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Requiring transfusion | Surgical and medical procedures | Non-systematic Assessment |
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Non randomized observational registry
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DeeAnn Tinjum | Boston Scientific Corporation | 763-450-8707 | deeann.tinjum@bsci.com |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D013927 | Thrombosis |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
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The # of patients that were exposed to each treatment at least once in the given thrombotic condition.
| Index Procedure |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Hemodialysis Access | Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter. |
| BG003 | Other Thrombotic Conditions | Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Deep Vein Thrombosis | Patients treated with a midlength Angiojet catheter for deep vein thrombosis |
| OG002 | Hemodialysis Access | Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites |
| OG003 | Other Thrombotic Conditions | Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access |
|
|
|
| Secondary | Rethrombosis | The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure). | Posted | Number | Participants | 3 Month Follow Up |
|
|
|
| Secondary | Description of Treatments by Thrombotic Condition | The # of patients that were exposed to each treatment at least once in the given thrombotic condition. | Posted | Number | Participants | Index Procedure |
|
|
|
| 6 |
| 198 |
| 0 |
| 198 |
| EG001 | Deep Vein Thrombosis | Patients with deep vein thrombosis treated with a midlength AngioJet catheter. | 2 | 170 | 0 | 170 |
| EG002 | Hemodialysis Access | Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter. | 0 | 72 | 0 | 72 |
| EG003 | Other Thrombotic Conditions | Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter. | 0 | 12 | 0 | 12 |
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Pancreatitis | Endocrine disorders | Non-systematic Assessment |
|
| Hemolytic Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Elevated Creatinine | Renal and urinary disorders | Non-systematic Assessment |
|
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| AngioJet Thrombectomy + Lytic Delivery |
|
| Balloon Angioplasty |
|
| Stent Placement |
|
| Atherectomy |
|
| Filter Placement |
|
| Catheter Directed Thrombolysis |
|
| Non AngioJet Thrombectomy |
|