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Project suspended by sponsor
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To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BlueLeaf System | Experimental | The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BlueLeaf System | Device | The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment | Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up | Baseline, 7-day, 30-day |
| Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) | Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit | 30-day post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment | Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging | 90-day, 210-day |
| Change in Reflux Time (RT) in the Primary Treated Vein Segment |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Technical Success | Procedure technical success is defined as delivery of the system to the target vessel and formation of at least one mobile autogenous valve (as measured with intravascular ultrasound (IVUS) or venography following valve formation) without target vessel occlusion at the conclusion of the index procedure | Procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Elkins | Intervene, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred | Camperdown | New South Wales | 2050 | Australia | ||
| Prince of Wales |
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Not applicable - Pre-assignment was not part of the protocol
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| ID | Title | Description |
|---|---|---|
| FG000 | BlueLeaf System | The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. BlueLeaf System: The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function; target vessel segments include: Proximal Femoral Vein (FV), Distal FV and Mid-Popliteal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Clinical investigation was terminated prematurely by the Sponsor; the data is available for 11 subjects (which is the analysis cohort).
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| ID | Title | Description |
|---|---|---|
| BG000 | BlueLeaf System | The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. BlueLeaf System: The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment | Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up | Subjects that underwent the investigational procedure and were seen at the 30-day follow-up | Posted | Mean | Standard Deviation | percentage change from Baseline | Baseline, 7-day, 30-day |
|
Up to 210-days post-procedure (longest follow-up available at the time of trial termination)
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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 | BlueLeaf System | The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. BlueLeaf System: The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Site Related | Injury, poisoning and procedural complications | Systematic Assessment | pain, bruising, bleeding, infection, hematoma |
The trial was terminated early leading to a limited number of subjects analyzed. Specifically, there was limited data available for reporting purposes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | InterVene, Inc. | 6509957137 | clinsupport@intervene-med.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2021 | Jul 28, 2025 | Prot_SAP_000.pdf |
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prospective, non-randomized, multicenter pre-market feasibility study
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Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline |
| 90-day, 210-day |
| Average Revised Venous Clinical Severity Score (rVCSS) |
Assessment of the average (mean) rVCSS at Baseline, 30D and 90D. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). A higher total score would indicate a worse outcome (total score can range from 0 to 30); the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. |
| Baseline, 30-day, 90-day |
| Change in Revised Venous Clinical Severity Score (rVCSS) | Assessment of the average (mean) change in rVCSS at 30D and 90D compared to Baseline. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). An increase in total score over time would indicate a worse outcome; the outcome is reported as the average (mean) numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Revised Venous Clinical Severity Score"). | 30-day, 90-day |
| Average Villalta Scale Score | Assessment of the average (mean) Villalta Scale Score at Baseline, 30D, and 90D. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease. | Baseline, 30-day, 90-day |
| Change in Villalta Scale Score | Assessment of average (mean) change in Villalta Scale Score at 30D and 90D compared to Baseline. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Villalta Scale Score"). A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease. | 30-day, 90-day |
| Average VEINES-QoL/Sym Score | Assessment of the average (mean) VEINES-QoL/Sym Score at Baseline, 30D, 90D and 210D. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). VEINES-QoL/Sym scores can range from 0-100, where higher scores indicate better outcomes (higher quality of life and less severe symptoms). The calculated mean VEINES-QoL/Sym scores at 30D, 90D and 210D post-procedure are provided. | Baseline, 30-day, 90-day, 210-day |
| Change in VEINES-QoL/Sym Score | Assessment of the change in the median (min, max) VEINES-QoL/Sym Score at 30D, 90D and 210D compared to Baseline. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). The outcome is reported as the change in median (min, max) score at 30D, 90D and 210D compared to the Baseline score (for Baseline scores refer to outcome measure "Average VEINES-QoL/Sym Score"). | 30-day, 90-day, 210-day |
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| Vancouver Coastal Health Research Institute | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Auckland City Hospital | Auckland | New Zealand |
| Clinical Trials New Zealand Ltd | Hamilton | New Zealand |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Study Limb | Count of Participants | Participants |
|
| Duration of Chronic Venous Insufficiency (CVI) | Mean | Standard Deviation | years |
|
| Prior Deep Vein Thrombosis (DVT) | Count of Participants | Participants |
|
| Anticoagulant Use at Baseline | Count of Participants | Participants |
|
| Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification | Count of Participants | Participants |
|
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. BlueLeaf System: The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. |
| OG002 | BlueLeaf System - Mid Popliteal Segment | The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. BlueLeaf System: The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. |
|
|
| Primary | Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) | Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit | Subjects that underwent the investigational procedure, were seen at the 30-day follow-up and imaging study was performed | Posted | Count of Participants | Participants | 30-day post-procedure |
|
|
|
| Secondary | Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment | Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging | Subjects that underwent the investigational procedure and were seen at the 90-day and 210-day follow-up; 90-day: data for six (6) subjects are available at this timepoint; 210-day: data for two (2) subjects are available at this timepoint | Posted | Number | participants | 90-day, 210-day |
|
|
|
| Secondary | Change in Reflux Time (RT) in the Primary Treated Vein Segment | Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline | Subjects that underwent the investigational procedure and were seen at the 90-day and 210-day follow-up; 90-day: data for six (6) subjects are available at this timepoint; 210-day: data for two (2) subjects are available at this timepoint | Posted | Mean | Standard Deviation | percent change from baseline values | 90-day, 210-day |
|
|
|
| Other Pre-specified | Procedure Technical Success | Procedure technical success is defined as delivery of the system to the target vessel and formation of at least one mobile autogenous valve (as measured with intravascular ultrasound (IVUS) or venography following valve formation) without target vessel occlusion at the conclusion of the index procedure | Subjects that underwent the investigational procedure | Posted | Count of Participants | Participants | Procedure |
|
|
|
| Other Pre-specified | Average Revised Venous Clinical Severity Score (rVCSS) | Assessment of the average (mean) rVCSS at Baseline, 30D and 90D. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). A higher total score would indicate a worse outcome (total score can range from 0 to 30); the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. | Subjects that underwent the investigational procedure and were seen at the 30-day and 90-day follow-up; 30-day and 90-day: data for six (6) subjects are available at these timepoints | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30-day, 90-day |
|
|
|
| Other Pre-specified | Change in Revised Venous Clinical Severity Score (rVCSS) | Assessment of the average (mean) change in rVCSS at 30D and 90D compared to Baseline. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). An increase in total score over time would indicate a worse outcome; the outcome is reported as the average (mean) numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Revised Venous Clinical Severity Score"). | Subjects that underwent the investigational procedure and were seen at the 30-day and 90-day follow-up; 30-day and 90-day: data for six (6) subjects are available at these timepoints | Posted | Mean | Standard Deviation | score on a scale | 30-day, 90-day |
|
|
|
| Other Pre-specified | Average Villalta Scale Score | Assessment of the average (mean) Villalta Scale Score at Baseline, 30D, and 90D. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease. | Subjects that underwent the investigational procedure and were seen at the 30-day and 90-day follow-up; data for seven (7) subjects are available at these timepoints | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30-day, 90-day |
|
|
|
| Other Pre-specified | Change in Villalta Scale Score | Assessment of average (mean) change in Villalta Scale Score at 30D and 90D compared to Baseline. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Villalta Scale Score"). A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease. | Subjects that underwent the investigational procedure and were seen at the 30-day and 90-day follow-up; data for seven (7) subjects are available at these timepoints | Posted | Mean | Standard Deviation | score on a scale | 30-day, 90-day |
|
|
|
| Other Pre-specified | Average VEINES-QoL/Sym Score | Assessment of the average (mean) VEINES-QoL/Sym Score at Baseline, 30D, 90D and 210D. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). VEINES-QoL/Sym scores can range from 0-100, where higher scores indicate better outcomes (higher quality of life and less severe symptoms). The calculated mean VEINES-QoL/Sym scores at 30D, 90D and 210D post-procedure are provided. | Subjects that underwent the investigational procedure and were seen at the 30-day, 90-day follow-up and 210-day follow-up; Baseline: data for eleven (11) subjects are available at this timepoint; 30-day: data for ten (10) subjects are available at this timepoint; 90-day: data for seven (7) subjects are available at this timepoint; 210-day: data for two (2) subjects are available at this timepoint | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30-day, 90-day, 210-day |
|
|
|
| Other Pre-specified | Change in VEINES-QoL/Sym Score | Assessment of the change in the median (min, max) VEINES-QoL/Sym Score at 30D, 90D and 210D compared to Baseline. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). The outcome is reported as the change in median (min, max) score at 30D, 90D and 210D compared to the Baseline score (for Baseline scores refer to outcome measure "Average VEINES-QoL/Sym Score"). | Subjects that underwent the investigational procedure and were seen at the 30-day, 90-day follow-up and 210-day follow-up; 30-day: data for ten (10) subjects are available at this timepoint; 90-day: data for seven (7) subjects are available at this timepoint; 210-day: data for two (2) subjects are available at this timepoint | Posted | Median | Full Range | score on a scale | 30-day, 90-day, 210-day |
|
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|
| 0 |
| 11 |
| 3 |
| 11 |
| 11 |
| 11 |
| Access site injury | Injury, poisoning and procedural complications | Systematic Assessment | unhealed access site |
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| Respiratory arrest | Injury, poisoning and procedural complications | Systematic Assessment | respiratory depression |
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| Autogenous Valve Formation Related | Surgical and medical procedures | Systematic Assessment | mural thrombus, asymptomatic arteriovenous (AV) fistula, bruising and pain |
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| Nausea | Injury, poisoning and procedural complications | Systematic Assessment |
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| Bruising of hand and wrist | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Bleeding at biopsy site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Infection of pre-existing ulcer | Infections and infestations | Systematic Assessment |
|
| Fall due to loss of balance | General disorders | Systematic Assessment |
|
| Feeling unwell | General disorders | Systematic Assessment |
|
Not provided
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| 210-day |
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| 210-day % change from Baseline |
|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
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| VEINES-Sym: 90-day |
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| VEINES-Sym: 210-day |
|
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| VEINES-QoL: Baseline |
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| VEINES-QoL: 30-day |
|
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| VEINES-QoL: 90-day |
|
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| VEINES-QoL: 210-day |
|
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| VEINES-Sym: 210-day change in median score from Baseline |
|
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| VEINES-QoL: 30-day change in median score from Baseline |
|
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| VEINES-QoL: 90-day change in median score from Baseline |
|
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| VEINES-QoL: 210-day change in median score from Baseline |
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