Peripheral Vascular Diseases, Thrombosis, Venous Thrombosis
Conditions
Keywords
Peripheral Thrombosis, DVT, Limb Ischemia, AV Access, AngioJet, Thrombectomy
Brief summary
This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.
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.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Final Angiographic Results | Index Procedure ( pre-endovascular treatment and post-endovascular treatment) | 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: 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 value from the final value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rethrombosis | 3 Month Follow Up | The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure). |
| Description of Treatments by Thrombotic Condition | Index Procedure | The # of patients that were exposed to each treatment at least once in the given thrombotic condition. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Limb Ischemia Patients with limb ischemia treated with a midlength AngioJet catheter. | 198 |
| Deep Vein Thrombosis Patients with deep vein thrombosis treated with a midlength AngioJet catheter. | 170 |
| Hemodialysis Access Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter. | 72 |
| 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. | 12 |
| Total | 452 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 3 Month Follow Up | Death | 8 | 3 | 2 | 0 |
| 3 Month Follow Up | Lost to Follow-up | 15 | 20 | 3 | 0 |
| Index Procedure-Discharge | Death | 6 | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | Limb Ischemia | Deep Vein Thrombosis | Hemodialysis Access | Other Thrombotic Conditions | Total |
|---|---|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 14 | 52 years STANDARD_DEVIATION 17 | 63 years STANDARD_DEVIATION 13 | 63 years STANDARD_DEVIATION 18 | 61 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 198 participants | 170 participants | 72 participants | 12 participants | 452 participants |
| Sex: Female, Male Female | 88 Participants | 64 Participants | 34 Participants | 6 Participants | 192 Participants |
| Sex: Female, Male Male | 110 Participants | 106 Participants | 38 Participants | 6 Participants | 260 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 / 198 | 0 / 170 | 0 / 72 | 0 / 12 |
| serious Total, serious adverse events | 6 / 198 | 2 / 170 | 0 / 72 | 0 / 12 |
Outcome results
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: 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 value from the final value.
Time frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment)
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Limb Ischemia | Change From Baseline to Final Angiographic Results | Baseline (pre-treatment) Angiograph Value | 1.32 Occlusion Index | Standard Error 0.04 |
| Limb Ischemia | Change From Baseline to Final Angiographic Results | Levels of Change (baseline minus final values) | 2.36 Occlusion Index | Standard Error 0.06 |
| Limb Ischemia | Change From Baseline to Final Angiographic Results | Final (post-treatment) Angiograph Value | 3.67 Occlusion Index | Standard Error 0.05 |
| Deep Vein Thrombosis | Change From Baseline to Final Angiographic Results | Baseline (pre-treatment) Angiograph Value | 1.37 Occlusion Index | Standard Error 0.04 |
| Deep Vein Thrombosis | Change From Baseline to Final Angiographic Results | Levels of Change (baseline minus final values) | 2.30 Occlusion Index | Standard Error 0.05 |
| Deep Vein Thrombosis | Change From Baseline to Final Angiographic Results | Final (post-treatment) Angiograph Value | 3.67 Occlusion Index | Standard Error 0.04 |
| Hemodialysis Access | Change From Baseline to Final Angiographic Results | Final (post-treatment) Angiograph Value | 3.80 Occlusion Index | Standard Error 0.07 |
| Hemodialysis Access | Change From Baseline to Final Angiographic Results | Baseline (pre-treatment) Angiograph Value | 1.16 Occlusion Index | Standard Error 0.05 |
| Hemodialysis Access | Change From Baseline to Final Angiographic Results | Levels of Change (baseline minus final values) | 2.63 Occlusion Index | Standard Error 0.08 |
| Other Thrombotic Conditions | Change From Baseline to Final Angiographic Results | Baseline (pre-treatment) Angiograph Value | 1.89 Occlusion Index | Standard Error 0.14 |
| Other Thrombotic Conditions | Change From Baseline to Final Angiographic Results | Levels of Change (baseline minus final values) | 1.63 Occlusion Index | Standard Error 0.18 |
| Other Thrombotic Conditions | Change From Baseline to Final Angiographic Results | Final (post-treatment) Angiograph Value | 3.54 Occlusion Index | Standard Error 0.14 |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
Secondary
Description of Treatments by Thrombotic Condition
The # of patients that were exposed to each treatment at least once in the given thrombotic condition.
Time frame: Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limb Ischemia | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy + Lytic Delivery | 121 Participants |
| Limb Ischemia | Description of Treatments by Thrombotic Condition | Non AngioJet Thrombectomy | 11 Participants |
| Limb Ischemia | Description of Treatments by Thrombotic Condition | Balloon Angioplasty | 144 Participants |
| Limb Ischemia | Description of Treatments by Thrombotic Condition | Stent Placement | 96 Participants |
| Limb Ischemia | Description of Treatments by Thrombotic Condition | Atherectomy | 8 Participants |
| Limb Ischemia | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy without Lytic | 70 Participants |
| Limb Ischemia | Description of Treatments by Thrombotic Condition | Filter Placement | 8 Participants |
| Limb Ischemia | Description of Treatments by Thrombotic Condition | Catheter Directed Thrombolysis | 76 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | Filter Placement | 34 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | Catheter Directed Thrombolysis | 79 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | Stent Placement | 48 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy + Lytic Delivery | 144 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | Atherectomy | 0 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | Non AngioJet Thrombectomy | 6 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | Balloon Angioplasty | 120 Participants |
| Deep Vein Thrombosis | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy without Lytic | 78 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy + Lytic Delivery | 4 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | Balloon Angioplasty | 59 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | Stent Placement | 30 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy without Lytic | 68 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | Filter Placement | 0 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | Catheter Directed Thrombolysis | 1 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | Non AngioJet Thrombectomy | 3 Participants |
| Hemodialysis Access | Description of Treatments by Thrombotic Condition | Atherectomy | 0 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | Non AngioJet Thrombectomy | 0 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy without Lytic | 6 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | Balloon Angioplasty | 4 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | Stent Placement | 3 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | Atherectomy | 0 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | Filter Placement | 6 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | Catheter Directed Thrombolysis | 3 Participants |
| Other Thrombotic Conditions | Description of Treatments by Thrombotic Condition | AngioJet Thrombectomy + Lytic Delivery | 8 Participants |
Secondary
Rethrombosis
The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).
Time frame: 3 Month Follow Up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Limb Ischemia | Rethrombosis | 17 Participants |
| Deep Vein Thrombosis | Rethrombosis | 11 Participants |
| Hemodialysis Access | Rethrombosis | 14 Participants |
| Other Thrombotic Conditions | Rethrombosis | 0 Participants |