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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.
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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 a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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.
| Day 1 |
| Rethrombosis | The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up. | 3 Month , 6 Month and 12 Month Follow Up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Community population
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Blitz, MD | Chilton Memorial Hospital | Principal Investigator |
| Robert Lookstein, MD | Icahn School of Medicine at Mount Sinai | Study Director |
| Ali Amin, MD | The Reading Hospital & Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Heart, PLLC | Glendale | Arizona | 85306 | United States | ||
| John C. Lincoln Deer Valley Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25824314 | Derived | Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29. |
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Patients presenting at a participating site who were clinically indicated for a peripheral interventional (arterial, venous or hemodialysis access) procedure with the AngioJet Thrombectomy System were offered the opportuntity to participate. Patients were recruited from January 2010 thru June 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Limb Ischemia | Patients presenting with limb ischemia for treatment |
| FG001 | Deep Vein Thrombosis | Patients presenting with deep vein thrombosis for treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phoenix |
| Arizona |
| 85029 |
| United States |
| Good Samaritan Hospital | Los Angeles | California | 90017 | United States |
| Christiana Care Health System | Newark | Delaware | 19718 | United States |
| University of Florida- College of Medicine | Jacksonville | Florida | 32209 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | United States |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| Chris Recknor PC | Gainesville | Georgia | 30501 | United States |
| Indiana University Health Arnett | Lafayette | Indiana | 47905 | United States |
| Iowa Health | Des Moines | Iowa | 50263 | United States |
| Cardiovascular Consultants | Bossier City | Louisiana | 71111 | United States |
| Terrebonne General Medical Center | Houma | Louisiana | 70360 | United States |
| Regional Medical Center of Acadiana | Lafayette | Louisiana | 70506 | United States |
| Chilton Memorial Hospital | Pompton Plains | New Jersey | 07444 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Grant Medical Center | Columbus | Ohio | 43215 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45435 | United States |
| The University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| St Luke's Hospital & Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| The Reading Hospital & Medical Center | Reading | Pennsylvania | 19611 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| University of South Carolina | Charleston | South Carolina | 29401 | United States |
| North Central Heart Institute | Sioux Falls | South Dakota | 57108 | United States |
| Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| University of Tennessee - Knoxville | Knoxville | Tennessee | 37920 | United States |
| Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Winnipeg Regional Health Authority | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Städtisches Klinikum Karlsruhe gGmbH | Karlsruhe | Germany |
| University of Naples | Naples | Italy |
| National Institute of CV Diseases | Bratislava | Slovakia |
| FG002 | Hemodialysis Access | Patients presenting with thrombosed hemodialysis access for treatment |
| FG003 | Other Thrombotic Conditions | Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment |
| 3 Month Follow Up |
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| 6 Month Follow Up |
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| 12 Month Follow Up |
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| COMPLETED |
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| NOT COMPLETED |
|
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Descriptive Analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Limb Ischemia | Patients presenting with limb ischemia for treatment |
| BG001 | Deep Vein Thrombosis | Patients presenting with deep vein thrombosis for treatment |
| BG002 | Hemodialysis Access | Patients presenting with thrombosed hemodialysis access for treatment |
| BG003 | Other Thrombotic Conditions | Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 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.
| Intention to Treat (ITT) | Posted | Mean | Standard Error | Units on a Scale | Day 1 |
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| Primary | Rethrombosis | The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up. | Posted | Number | participants | 3 Month , 6 Month and 12 Month Follow Up |
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| Secondary | 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 | Posted | Number | participants | Day 1 |
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Index Procedure thru 12 Month Follow Up
Events that were related to the 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 presenting with limb ischemia for treatment | 2 | 212 | 0 | 212 | ||
| EG001 | Deep Vein Thrombosis | Patients presenting with deep vein thrombosis for treatment | 2 | 201 | 0 | 201 | ||
| EG002 | Hemodialysis Access | Patients presenting with thrombosed hemodialysis access for treatment | 0 | 73 | 0 | 73 | ||
| EG003 | Other Thrombotic Conditions | Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment | 0 | 14 | 0 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Requiring Transfusion | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DeeAnn Tinjum | Boston Scientific Corporation | 763-450-8707 | deeann.tinjum@bsci.com |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
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| Male |
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| Slovakia |
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| Germany |
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| Italy |
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| Final Value |
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| Levels of Change |
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| <0.0001 |
| 2-Sided |
| No |
| Superiority or Other |
| Mixed Models Analysis | Alternative hypothesis is change in occlusion >0 | <0.0001 | 2-Sided | No | Superiority or Other |
| Mixed Models Analysis | Alternative hypothesis is change in occlusion >0 | <0.0001 | 2-Sided | No | Superiority or Other |
| Participants |
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| Participants |
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