Embolism and Thrombosis, Peripheral Vascular Disease, Venous Thrombosis
Conditions
Brief summary
The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.
Detailed description
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | 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. 1. complete occlusion (\>90% occlusion); 2. substantial occlusion (50-90% occlusion OR \<50% occlusion and \>3cm in length); 3. partial occlusion (\<50% occlusion AND \<3cm in length) 4. 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concomitant Treatments Used With the AngioJet® System | Day 1 | The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure |
Countries
Canada, Germany, Italy, Slovakia, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Limb Ischemia Patients presenting with limb ischemia for treatment | 212 |
| Deep Vein Thrombosis Patients presenting with deep vein thrombosis for treatment | 201 |
| Hemodialysis Access Patients presenting with thrombosed hemodialysis access for treatment | 73 |
| Other Thrombotic Conditions Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment | 14 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 14 | 8 | 8 | 1 |
| Overall Study | Lost to Follow-up | 22 | 39 | 18 | 2 |
Baseline characteristics
| Characteristic | Limb Ischemia | Deep Vein Thrombosis | Hemodialysis Access | Other Thrombotic Conditions | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 11.59 | 51.3 years STANDARD_DEVIATION 16.37 | 61.6 years STANDARD_DEVIATION 13.94 | 56.5 years STANDARD_DEVIATION 12.07 | 58.1 years STANDARD_DEVIATION 15.16 |
| Region of Enrollment Germany | 1 participants | 0 participants | 0 participants | 1 participants | 2 participants |
| Region of Enrollment Italy | 3 participants | 0 participants | 0 participants | 0 participants | 3 participants |
| Region of Enrollment Slovakia | 54 participants | 11 participants | 0 participants | 0 participants | 65 participants |
| Region of Enrollment United States | 154 participants | 190 participants | 73 participants | 13 participants | 430 participants |
| Sex: Female, Male Female | 74 Participants | 93 Participants | 36 Participants | 5 Participants | 208 Participants |
| Sex: Female, Male Male | 138 Participants | 108 Participants | 37 Participants | 9 Participants | 292 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 212 | 0 / 201 | 0 / 73 | 0 / 14 |
| serious Total, serious adverse events | 2 / 212 | 2 / 201 | 0 / 73 | 0 / 14 |
Outcome results
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. 1. complete occlusion (\>90% occlusion); 2. substantial occlusion (50-90% occlusion OR \<50% occlusion and \>3cm in length); 3. partial occlusion (\<50% occlusion AND \<3cm in length) 4. 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.
Time frame: Day 1
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Limb Ischemia | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Levels of Change | 2.45 Units on a Scale | Standard Error 0.05 |
| Limb Ischemia | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Final Value | 3.76 Units on a Scale | Standard Error 0.04 |
| Limb Ischemia | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Baseline Value | 1.31 Units on a Scale | Standard Error 0.03 |
| Deep Vein Thrombosis | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Final Value | 3.73 Units on a Scale | Standard Error 0.03 |
| Deep Vein Thrombosis | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Baseline Value | 1.33 Units on a Scale | Standard Error 0.03 |
| Deep Vein Thrombosis | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Levels of Change | 2.40 Units on a Scale | Standard Error 0.04 |
| Hemodialysis Access | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Baseline Value | 1.36 Units on a Scale | Standard Error 0.06 |
| Hemodialysis Access | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Final Value | 3.87 Units on a Scale | Standard Error 0.04 |
| Hemodialysis Access | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Levels of Change | 2.50 Units on a Scale | Standard Error 0.07 |
| Other Thrombotic Conditions | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Final Value | 3.75 Units on a Scale | Standard Error 0.12 |
| Other Thrombotic Conditions | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Levels of Change | 1.95 Units on a Scale | Standard Error 0.18 |
| Other Thrombotic Conditions | Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | Baseline Value | 1.80 Units on a Scale | Standard Error 0.16 |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Primary
Rethrombosis
The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.
Time frame: 3 Month , 6 Month and 12 Month Follow Up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limb Ischemia | Rethrombosis | 3 Month Follow Up | 21 participants |
| Limb Ischemia | Rethrombosis | 12 Month Follow Up | 9 participants |
| Limb Ischemia | Rethrombosis | 6 Month Follow Up | 9 participants |
| Deep Vein Thrombosis | Rethrombosis | 3 Month Follow Up | 22 participants |
| Deep Vein Thrombosis | Rethrombosis | 12 Month Follow Up | 3 participants |
| Deep Vein Thrombosis | Rethrombosis | 6 Month Follow Up | 4 participants |
| Hemodialysis Access | Rethrombosis | 6 Month Follow Up | 12 participants |
| Hemodialysis Access | Rethrombosis | 3 Month Follow Up | 15 participants |
| Hemodialysis Access | Rethrombosis | 12 Month Follow Up | 7 participants |
| Other Thrombotic Conditions | Rethrombosis | 3 Month Follow Up | 0 participants |
| Other Thrombotic Conditions | Rethrombosis | 12 Month Follow Up | 0 participants |
| Other Thrombotic Conditions | Rethrombosis | 6 Month Follow Up | 0 participants |
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
Time frame: Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy without Lytic | 102 participants |
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy + Lytic Delivery | 146 participants |
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | Balloon Angioplasty | 164 participants |
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | Stent Placement | 124 participants |
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | Catheter Directed Thrombolysis | 106 participants |
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | Atherectomy | 9 participants |
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | Filter Placement | 17 participants |
| Limb Ischemia | Concomitant Treatments Used With the AngioJet® System | Non AngioJet Thrombectomy | 31 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | Atherectomy | 0 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | Catheter Directed Thrombolysis | 143 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy + Lytic Delivery | 175 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | Non AngioJet Thrombectomy | 14 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | Filter Placement | 51 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | Stent Placement | 71 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | Balloon Angioplasty | 157 participants |
| Deep Vein Thrombosis | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy without Lytic | 94 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | Filter Placement | 0 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | Balloon Angioplasty | 69 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | Stent Placement | 29 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | Catheter Directed Thrombolysis | 0 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | Atherectomy | 0 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | Non AngioJet Thrombectomy | 45 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy without Lytic | 67 participants |
| Hemodialysis Access | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy + Lytic Delivery | 15 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | Balloon Angioplasty | 6 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | Stent Placement | 2 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy + Lytic Delivery | 9 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | AngioJet Thrombectomy without Lytic | 6 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | Catheter Directed Thrombolysis | 2 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | Non AngioJet Thrombectomy | 2 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | Filter Placement | 0 participants |
| Other Thrombotic Conditions | Concomitant Treatments Used With the AngioJet® System | Atherectomy | 0 participants |