Iliofemoral Venous Obstruction
Conditions
Brief summary
Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.
Interventions
DEVICEAbre venous self-expanding stent system
venous stent
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is ≥ 18 and ≤ 80 years of age; 2. Patient has at least one of the following clinical manifestations (i.e. symptoms and/or signs) of venous disease in lower extremity: * CEAP score ≥ 3 * Venous Clinical Severity Score pain score (VCSS) ≥2 * Suspected deep vein thrombosis (DVT); 3. Patient is willing and capable of complying with specified follow-up evaluations at the specified times; 4. Patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Board. 5. Patient has diagnosis of non-malignant venous obstruction within the common iliac, external iliac, and/or common femoral vein. The proximal point of the obstruction may extend to the iliac venous confluence of the inferior vena cava and the distal point may be at or above the deep femoral vein. Diagnosis must be made based on objective imaging by using venography and/or intravascular ultrasound (IVUS); 6. Patient has an obstructive lesion defined as: * Occluded, or * ≥50% in diameter reduction on venography or IVUS, or * ≥50% area reduction on IVUS 7. Acute DVT patients should be treated with the Abre stent within 14 days after onset of symptoms. Patients with acute DVT must first undergo successful treatment of acute thrombus by catheter based techniques; successful treatment is defined as 30% or less residual thrombus by venogram, as determined by physician, no bleeding, no symptomatic pulmonary embolism (confirmed by imaging), and no renal compromise (renal compromise defined as GFR\>30). Patients with underlying obstructive lesions can then be included in the study within the same procedure; 8. Target vessel can accommodate a 9 French Sheath, from insertion site to target segment; 9. Exchangeable guidewire must cross target lesion(s) with successful predilation.
Exclusion criteria
1. Patient with DVT in the target limb of which the onset of symptoms is between 15 days and 6 months prior to planned treatment or patient has an acute DVT anywhere else than in the target vessel; 2. Patient has peripheral arterial disease causing symptoms in target limb; 3. Patient is pregnant, female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure; 4. Patient has a known or suspected systemic infection at the time of the index procedure; 5. Patient has a planned percutaneous or surgical intervention within 30 days prior or 30 days following index procedure, or a contralateral iliofemoral lesion requiring planned treatment within 12 months; 6. Patient requires femoral endovenectomy and patch venoplasty, greater saphenous vein ablation, and/or small saphenous vein stripping during the index procedure; 7. Patient has an active vasculitic inflammatory disorder (e.g. Behcet disease) predisposing the patient to thrombosis and requiring systemic corticosteroid therapy; 8. Patient has impaired renal function (GFR \< 30) or is on dialysis; 9. Patient has a platelet count \< 50,000 cells/mm3 or \> 1,000,000 cells/mm3 and/or a White Blood Cell count \< 3,000 cells/mm3 or \> 12,500 cells/mm3; 10. Patient has a history of bleeding diathesis or either a history or presence of heparin induced thrombocytopenia antibodies; 11. Patient has a known hypersensitivity or contraindication to antiplatelets or anticoagulation, nitinol, or a contrast sensitivity that cannot be adequately pre-medicated; 12. Patient has presence of other severe co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g. congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy \< 1 year); 13. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. Patient must be able to consent for themselves; 14. Patient is currently participating in another investigational drug or device study or observational competitive study. 15. Patient has a vena cava obstruction or lesion extending into the inferior vena cava (IVC), or the presence of bilateral iliofemoral venous lesions requiring planned treatment within 12 months; 16. Patient has significant venous bleeding, arterial dissection or other injury requiring additional percutaneous or surgical intervention prior to enrollment; 17. Patient has a previously placed stent in the ipsilateral venous vasculature; 18. Patient has disease that precludes safe advancement of the venous stent to the target lesion(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 12 Months | Freedom from occlusion of the stented segment; Freedom from restenosis \>=50%; and Freedom from clinically-driven target lesion revascularization |
| Composite Major Adverse Events | 30 Days | The components of the Major Adverse Events include: All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Index Procedure Success | 30 days | Lesion success without procedure-related MAEs prior to hospital discharge |
| Primary Patency | 24 Months, 36 Months | Primary Patency: Defined as meeting all of the following criteria: * Freedom from occlusion of the stented segment of the target lesion; * Freedom from restenosis ≥50% of the stented segment of the target lesion; * Freedom from clinically driven target lesion revascularization. |
| Primary Assisted Patency | 12 Months, 24 Months, 36 Months | Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.) |
| Secondary Patency | 12 Months, 24 Months, 36 Months | Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion. |
| Stent Fracture | 30 Days, 12 Months, 24 Months, 36 Months | X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively. |
| Target Lesion Revascularization | 30 days, 6 months, 12 months, 24 months, 36 months | Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days. |
| Delayed Stent Migration | 12 Months, 24 Months, 36 Months | Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively. |
| Device Success | Index Procedure | Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure. |
| Major Bleeding Related to Index Procedure | 30 Days, 6 Months, 12 Months, 24 Months, 36 Months | A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure. |
| Re-Hospitalization | 0-180, 181-360, 361-720, 721-1080 and 0-1080 days | Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure. |
| Villalta Score | Baseline to 6 Months, 12 Months, 24 Months, 36 Months | Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A negative change is associated with improved outcome. |
| Venous Clinical Severity Score (VCSS) | Baseline to 6 Months, 12 Months, 24 Months, 36 Months | VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score. A negative change is associated with improved outcome. |
| EuroQol-5 Dimension (EQ-5D) Score | Baseline to 6 Months, 12 Months, 24 Months, 36 Months | Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores. |
| Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A positive change is associated with improved outcome. |
| Major Adverse Events | 6 Months, 12 Months, 24 Months, 36 Months | Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit. |
| Lesion Success Obtained at Index Procedure | Index Procedure | Venographic evidence of \<50% residual stenosis of the stented segment of the target lesion after post-dilation. |
Countries
France, Germany, Ireland, Italy, United Kingdom, United States
Participant flow
Recruitment details
Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between December 2017 and November 2018. Included subjects went on to have one or more Abre stents implanted. The first subject was included on December 19, 2017 and the last subject was included on November 29, 2018.
Pre-assignment details
Of the 260 enrolled subjects, 200 met inclusion criteria and were implanted with the Abre stent(s).
Participants by arm
| Arm | Count |
|---|---|
| ABRE Subjects included and implanted with one or more Abre stents | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | No 36-Month Follow-Up | 18 |
| Overall Study | Subject Incarcerated, Moved, or Refused | 4 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | ABRE |
|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 15.9 |
| Body Mass Index (BMI) | 29.5 kg/m^2 STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants |
| Race (NIH/OMB) White | 157 Participants |
| Region of Enrollment France | 22 participants |
| Region of Enrollment Germany | 11 participants |
| Region of Enrollment Ireland | 5 participants |
| Region of Enrollment Italy | 6 participants |
| Region of Enrollment United Kingdom | 28 participants |
| Region of Enrollment United States | 128 participants |
| Sex: Female, Male Female | 133 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 200 |
| other Total, other adverse events | 17 / 200 |
| serious Total, serious adverse events | 86 / 200 |
Outcome results
Primary
Composite Major Adverse Events
The components of the Major Adverse Events include: All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration
Time frame: 30 Days
Population: Proportion Rate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABRE | Composite Major Adverse Events | 4 Participants |
Comparison: The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:~H0: P ≥ PG vs. HA: P \< PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.~The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%.p-value: <0.0001Fisher Exact
Primary
Primary Patency
Freedom from occlusion of the stented segment; Freedom from restenosis \>=50%; and Freedom from clinically-driven target lesion revascularization
Time frame: 12 Months
Population: Proportion Rate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABRE | Primary Patency | 162 Participants |
Comparison: The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:~H0: π ≤ PG vs. HA: π \> PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%.p-value: <0.0001Fisher Exact
Secondary
Delayed Stent Migration
Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.
Time frame: 12 Months, 24 Months, 36 Months
Population: Included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABRE | Delayed Stent Migration | 24 Months | 0 Stent number |
| ABRE | Delayed Stent Migration | 36 Months | 0 Stent number |
| ABRE | Delayed Stent Migration | 12 Months | 0 Stent number |
Secondary
Device Success
Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.
Time frame: Index Procedure
Population: 302 Abre stents were implanted in 200 included subjects.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ABRE | Device Success | 302 Implanted Stents |
Secondary
EuroQol-5 Dimension (EQ-5D) Score
Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores.
Time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Population: Subjects with available data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D Index Score change from Baseline to 6 Months | 0.15 score on a scale | Standard Deviation 0.23 |
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D Index Score change from Baseline to 12 Months | 0.14 score on a scale | Standard Deviation 0.26 |
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D Index Score change from Baseline to 24 Months | 0.12 score on a scale | Standard Deviation 0.26 |
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D Index Score change from Baseline to 36 Months | 0.13 score on a scale | Standard Deviation 0.24 |
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D VAS change from baseline to 6 Months | 9.3 score on a scale | Standard Deviation 22 |
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D VAS change from baseline to 12 Months | 8.6 score on a scale | Standard Deviation 23.1 |
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D VAS change from baseline to 24 Months | 9.7 score on a scale | Standard Deviation 20.3 |
| ABRE | EuroQol-5 Dimension (EQ-5D) Score | EQ-5D VAS change from baseline to 36 Months | 7.7 score on a scale | Standard Deviation 23.7 |
Secondary
Index Procedure Success
Lesion success without procedure-related MAEs prior to hospital discharge
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABRE | Index Procedure Success | 198 Participants |
Secondary
Lesion Success Obtained at Index Procedure
Venographic evidence of \<50% residual stenosis of the stented segment of the target lesion after post-dilation.
Time frame: Index Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABRE | Lesion Success Obtained at Index Procedure | 200 Participants |
Secondary
Major Adverse Events
Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.
Time frame: 6 Months, 12 Months, 24 Months, 36 Months
Population: Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 180, 360, 720, and 1080 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABRE | Major Adverse Events | Within 6 Months | 4.5 Event % |
| ABRE | Major Adverse Events | Within 12 Months | 6.0 Event % |
| ABRE | Major Adverse Events | Within 24 Months | 8.6 Event % |
| ABRE | Major Adverse Events | Within 36 Months | 10.2 Event % |
Secondary
Major Bleeding Related to Index Procedure
A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure.
Time frame: 30 Days, 6 Months, 12 Months, 24 Months, 36 Months
Population: Subjects with an event or a minimum number of follow-up days per time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABRE | Major Bleeding Related to Index Procedure | 30 Days | 0 Participants |
| ABRE | Major Bleeding Related to Index Procedure | 6 Months | 0 Participants |
| ABRE | Major Bleeding Related to Index Procedure | 12 Months | 0 Participants |
| ABRE | Major Bleeding Related to Index Procedure | 24 Months | 0 Participants |
| ABRE | Major Bleeding Related to Index Procedure | 36 Months | 0 Participants |
Secondary
Primary Assisted Patency
Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)
Time frame: 12 Months, 24 Months, 36 Months
Population: SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABRE | Primary Assisted Patency | 12 Months | 97.0 Event-Free % |
| ABRE | Primary Assisted Patency | 24 Months | 90.2 Event-Free % |
| ABRE | Primary Assisted Patency | 36 Months | 84.8 Event-Free % |
Secondary
Primary Patency
Primary Patency: Defined as meeting all of the following criteria: * Freedom from occlusion of the stented segment of the target lesion; * Freedom from restenosis ≥50% of the stented segment of the target lesion; * Freedom from clinically driven target lesion revascularization.
Time frame: 24 Months, 36 Months
Population: SURVIVAL estimate using Kaplan-Meier method. Estimate made at 720 and 1080 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABRE | Primary Patency | 24 Months | 86.2 Event-Free % |
| ABRE | Primary Patency | 36 Months | 81.6 Event-Free % |
Secondary
Re-Hospitalization
Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure.
Time frame: 0-180, 181-360, 361-720, 721-1080 and 0-1080 days
Population: Subjects with an event or a minimum number of follow-up days per time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABRE | Re-Hospitalization | 0-6 Months | 11 Participants |
| ABRE | Re-Hospitalization | 6-12 Months | 5 Participants |
| ABRE | Re-Hospitalization | 12-24 Months | 6 Participants |
| ABRE | Re-Hospitalization | 24-36 Months | 5 Participants |
| ABRE | Re-Hospitalization | 0-36 Months | 20 Participants |
Secondary
Secondary Patency
Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.
Time frame: 12 Months, 24 Months, 36 Months
Population: SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABRE | Secondary Patency | 12 Month | 99.0 Event-Free % |
| ABRE | Secondary Patency | 24 Months | 91.8 Event-Free % |
| ABRE | Secondary Patency | 36 Months | 86.3 Event-Free % |
Secondary
Stent Fracture
X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.
Time frame: 30 Days, 12 Months, 24 Months, 36 Months
Population: X-ray for the 30-day visit was only required on the first 30 subjects; included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to 420 days for 12 months assessment, up to 780 days for 24 months assessment, and up to 1140 days for 36 months assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABRE | Stent Fracture | 30 Day | 0 Stents |
| ABRE | Stent Fracture | 12 Months | 0 Stents |
| ABRE | Stent Fracture | 24 Months | 0 Stents |
| ABRE | Stent Fracture | 36 Months | 0 Stents |
Secondary
Target Lesion Revascularization
Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months
Population: Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 30, 180, 360, 720, and 1080 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABRE | Target Lesion Revascularization | 30 Days | 3.0 Event % |
| ABRE | Target Lesion Revascularization | 6 Months | 7.5 Event % |
| ABRE | Target Lesion Revascularization | 12 Months | 11.1 Event % |
| ABRE | Target Lesion Revascularization | 24 Months | 14.7 Event % |
| ABRE | Target Lesion Revascularization | 36 Months | 16.3 Event % |
Secondary
Venous Clinical Severity Score (VCSS)
VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score. A negative change is associated with improved outcome.
Time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Population: Subjects with available data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABRE | Venous Clinical Severity Score (VCSS) | Change from Baseline to 6 Months | -4.0 score on a scale | Standard Deviation 3.7 |
| ABRE | Venous Clinical Severity Score (VCSS) | Change from Baseline to 12 Months | -4.6 score on a scale | Standard Deviation 4.3 |
| ABRE | Venous Clinical Severity Score (VCSS) | Change from Baseline to 24 Months | -4.8 score on a scale | Standard Deviation 4.4 |
| ABRE | Venous Clinical Severity Score (VCSS) | Change from Baseline to 36 Months | -4.5 score on a scale | Standard Deviation 3.9 |
Secondary
Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score
Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A positive change is associated with improved outcome.
Time frame: Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Population: Subjects with available data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES QoL change from Baseline to 6 Months | 22.2 score on a scale | Standard Deviation 25.3 |
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES QoL change from Baseline to 12 Months | 22.9 score on a scale | Standard Deviation 25.1 |
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES QoL change from Baseline to 36 Months | 21.4 score on a scale | Standard Deviation 25.2 |
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES Sym change from Baseline to 6 months | 22.3 score on a scale | Standard Deviation 23.6 |
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES Sym change from Baseline to 12 months | 20.9 score on a scale | Standard Deviation 24 |
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES Sym change from Baseline to 24 months | 20.4 score on a scale | Standard Deviation 26.9 |
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES Sym change from Baseline to 36 months | 20.2 score on a scale | Standard Deviation 24.9 |
| ABRE | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | VEINES QoL change from Baseline to 24 Months | 21.8 score on a scale | Standard Deviation 28.1 |
Secondary
Villalta Score
Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A negative change is associated with improved outcome.
Time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Population: Subjects with available data at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABRE | Villalta Score | Change from Baseline to 6 Months | -6.5 score on a scale | Standard Deviation 5.4 |
| ABRE | Villalta Score | Change from Baseline to 12 Months | -7.0 score on a scale | Standard Deviation 5.6 |
| ABRE | Villalta Score | Change from Baseline to 24 Months | -6.7 score on a scale | Standard Deviation 6.2 |
| ABRE | Villalta Score | Change from Baseline to 36 Months | -6.3 score on a scale | Standard Deviation 5.3 |