Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01086215 |
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Recruitment Status :
Completed
First Posted : March 15, 2010
Results First Posted : November 2, 2014
Last Update Posted : November 10, 2014
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| Condition or disease |
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| Peripheral Vascular Disease Embolism and Thrombosis Venous Thrombosis |
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.
| Study Type : | Observational |
| Actual Enrollment : | 500 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | July 2013 |
| Actual Study Completion Date : | September 2013 |
| Group/Cohort |
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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 a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
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- Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. [ Time Frame: Day 1 ]
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.
- 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/venographic value from the final value.
- Rethrombosis [ Time Frame: 3 Month , 6 Month and 12 Month Follow Up ]The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.
- Concomitant Treatments Used With the AngioJet® System [ Time Frame: Day 1 ]The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
- Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.
Exclusion Criteria:
- Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086215
Show 36 study locations
| Principal Investigator: | Lawrence Blitz, MD | Chilton Memorial Hospital | |
| Study Director: | Robert Lookstein, MD | Icahn School of Medicine at Mount Sinai | |
| Principal Investigator: | Ali Amin, MD | The Reading Hospital & Medical Center |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01086215 |
| Other Study ID Numbers: |
PEARLII |
| First Posted: | March 15, 2010 Key Record Dates |
| Results First Posted: | November 2, 2014 |
| Last Update Posted: | November 10, 2014 |
| Last Verified: | November 2014 |
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Thrombosis Embolism Vascular Diseases Venous Thrombosis Peripheral Vascular Diseases Peripheral Arterial Disease |
Embolism and Thrombosis Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |