Trial Outcomes & Findings for Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US) (NCT NCT04225806)
NCT ID: NCT04225806
Last Updated: 2025-08-19
Results Overview
* Symptomatic pulmonary embolism * DVT anywhere in the deep venous system of the treatment limb * Occlusive valve pocket thrombus (VPT) * Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention * Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.) * Device or procedure-related death
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
30-day post-procedure
Results posted on
2025-08-19
Participant Flow
Participant milestones
| Measure |
Investigational
Subjects will be treated with the investigational device and followed per protocol.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Investigational
Subjects will be treated with the investigational device and followed per protocol.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
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|---|---|
|
Overall Study
Trial termination
|
15
|
Baseline Characteristics
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
Baseline characteristics by cohort
| Measure |
Investigational
n=15 Participants
Subjects will be treated with the investigational device and followed per protocol.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
|
|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
|
Revised Venous Clinical Severity Score (rVCSS)
|
14.4 score on a scale
STANDARD_DEVIATION 4.2 • n=93 Participants
|
|
Deep Venous Thrombosis (DVT)
Right
|
5 Participants
n=93 Participants
|
|
Deep Venous Thrombosis (DVT)
Left
|
3 Participants
n=93 Participants
|
|
Deep Venous Thrombosis (DVT)
Bilateral
|
1 Participants
n=93 Participants
|
|
Deep Venous Thrombosis (DVT)
None
|
6 Participants
n=93 Participants
|
|
Diabetes
Type 1
|
0 Participants
n=93 Participants
|
|
Diabetes
Type 2
|
3 Participants
n=93 Participants
|
|
Diabetes
None
|
12 Participants
n=93 Participants
|
|
Smoker
Current
|
2 Participants
n=93 Participants
|
|
Smoker
Former
|
6 Participants
n=93 Participants
|
|
Smoker
Never
|
7 Participants
n=93 Participants
|
|
Chronic Kidney Disease
Yes
|
2 Participants
n=93 Participants
|
|
Chronic Kidney Disease
No
|
13 Participants
n=93 Participants
|
|
History of Stroke
Yes
|
0 Participants
n=93 Participants
|
|
History of Stroke
No
|
15 Participants
n=93 Participants
|
|
History of Malignancy
Yes, active
|
0 Participants
n=93 Participants
|
|
History of Malignancy
Yes, inactive
|
1 Participants
n=93 Participants
|
|
History of Malignancy
No
|
14 Participants
n=93 Participants
|
|
History of Peripheral Artery Disease (PAD)
Yes, active
|
1 Participants
n=93 Participants
|
|
History of Peripheral Artery Disease (PAD)
Yes, inactive
|
0 Participants
n=93 Participants
|
|
History of Peripheral Artery Disease (PAD)
No
|
14 Participants
n=93 Participants
|
|
History of Hypercoagulable Syndrome
Yes, active
|
2 Participants
n=93 Participants
|
|
History of Hypercoagulable Syndrome
Yes, inactive
|
0 Participants
n=93 Participants
|
|
History of Hypercoagulable Syndrome
No
|
13 Participants
n=93 Participants
|
|
History of Coronary Artery Disease
Yes
|
1 Participants
n=93 Participants
|
|
History of Coronary Artery Disease
No
|
14 Participants
n=93 Participants
|
|
History of Chronic Obstructive Pulmonary Disease (COPD)
Yes
|
1 Participants
n=93 Participants
|
|
History of Chronic Obstructive Pulmonary Disease (COPD)
No
|
14 Participants
n=93 Participants
|
|
History of Pulmonary Embolism
Yes
|
3 Participants
n=93 Participants
|
|
History of Pulmonary Embolism
No
|
12 Participants
n=93 Participants
|
|
History of Chronic Venous Insufficiency (CVI)
Yes
|
15 Participants
n=93 Participants
|
|
History of Chronic Venous Insufficiency (CVI)
No
|
0 Participants
n=93 Participants
|
|
Prior Superficial Vein Treatment
None
|
7 procedures
n=93 Participants
|
|
Prior Superficial Vein Treatment
Surgical stripping/ligation
|
4 procedures
n=93 Participants
|
|
Prior Superficial Vein Treatment
Foam sclerotherapy
|
3 procedures
n=93 Participants
|
|
Prior Superficial Vein Treatment
Endovenous ablation/closure
|
7 procedures
n=93 Participants
|
|
History of Congestive Heart Failure (CHF)
Yes
|
1 Participants
n=93 Participants
|
|
History of Congestive Heart Failure (CHF)
No
|
14 Participants
n=93 Participants
|
|
Prior Deep Venous System or Outflow Vessel Intervention
Yes
|
7 participants
n=93 Participants
|
|
Prior Deep Venous System or Outflow Vessel Intervention
No
|
8 participants
n=93 Participants
|
|
Prior Fem-pop Balloon Angioplasty
Right
|
2 procedures
n=93 Participants
|
|
Prior Fem-pop Balloon Angioplasty
Left
|
0 procedures
n=93 Participants
|
|
Prior Fem-pop Balloon Angioplasty
Bilateral
|
1 procedures
n=93 Participants
|
|
Prior Thrombectomy
Right
|
0 procedures
n=93 Participants
|
|
Prior Thrombectomy
Left
|
0 procedures
n=93 Participants
|
|
Prior Thrombectomy
Bilateral
|
0 procedures
n=93 Participants
|
|
Prior Venous Stenting
Right
|
2 procedures
n=93 Participants
|
|
Prior Venous Stenting
Left
|
2 procedures
n=93 Participants
|
|
Prior Venous Stenting
Bilateral
|
0 procedures
n=93 Participants
|
|
Prior Venous Valve Reconstruction Surgery
Right
|
0 procedures
n=93 Participants
|
|
Prior Venous Valve Reconstruction Surgery
Left
|
0 procedures
n=93 Participants
|
|
Prior Venous Valve Reconstruction Surgery
Bilateral
|
0 procedures
n=93 Participants
|
|
Prior Inferior Vena Cava (IVC) Filter Placement
Yes, filter still present
|
2 Participants
n=93 Participants
|
|
Prior Inferior Vena Cava (IVC) Filter Placement
Yes, filter not present
|
1 Participants
n=93 Participants
|
|
Prior Inferior Vena Cava (IVC) Filter Placement
No
|
12 Participants
n=93 Participants
|
|
History of Corona Virus Disease 2019 (COVID-19)
Previous
|
1 Participants
n=93 Participants
|
|
History of Corona Virus Disease 2019 (COVID-19)
Current
|
0 Participants
n=93 Participants
|
|
History of Corona Virus Disease 2019 (COVID-19)
None
|
12 Participants
n=93 Participants
|
|
History of Corona Virus Disease 2019 (COVID-19)
Unknown
|
2 Participants
n=93 Participants
|
|
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification
C3 - edema
|
0 Participants
n=93 Participants
|
|
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification
C4 - changes in skin and subcutaneous tissue secondary to chronic venous disease
|
0 Participants
n=93 Participants
|
|
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification
C5 - healed
|
7 Participants
n=93 Participants
|
|
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification
C6 - active venous ulcer
|
3 Participants
n=93 Participants
|
|
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification
C6r - recurrent active venous ulcer
|
5 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30-day post-procedurePopulation: All subjects that were treated with the investigational device
* Symptomatic pulmonary embolism * DVT anywhere in the deep venous system of the treatment limb * Occlusive valve pocket thrombus (VPT) * Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention * Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.) * Device or procedure-related death
Outcome measures
| Measure |
Investigational
n=15 Participants
Subjects will be treated with the investigational device and followed per protocol.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
|
|---|---|
|
Primary Safety Endpoint: The Number of Subjects Experiencing a Major Adverse Event (MAE), Composed of the Following
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30-days, 12-weeks, 210-days and 365-days post-procedurePopulation: Only available data is reported and therefore, the number analyzed may differ across the timepoints
Assessment of changes in the rVCSS; 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 VCSS would indicate a worse outcome.
Outcome measures
| Measure |
Investigational
n=15 Participants
Subjects will be treated with the investigational device and followed per protocol.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
|
|---|---|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
Baseline Score
|
14.1 score on a scale
Standard Deviation 4.2
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
30-day Score
|
13.5 score on a scale
Standard Deviation 5.4
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
Change from Baseline - 30-day
|
-0.4 score on a scale
Standard Deviation 5.5
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
12-week Score
|
12.6 score on a scale
Standard Deviation 4.8
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
Change from Baseline - 12-week
|
-1.4 score on a scale
Standard Deviation 5.4
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
210-day Score
|
11.3 score on a scale
Standard Deviation 5.3
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
Change from Baseline - 210-day
|
-2.4 score on a scale
Standard Deviation 4.3
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
365-day Score
|
11.5 score on a scale
Standard Deviation 4.8
|
|
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
Change from Baseline - 365-day
|
-2.3 score on a scale
Standard Deviation 4.3
|
Adverse Events
Investigational
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational
n=15 participants at risk
Subjects will be treated with the investigational device and followed per protocol.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
|
|---|---|
|
Injury, poisoning and procedural complications
Infection
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Hematoma
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cellulitis
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Vascular disorders
Bleeding varicosity
|
6.7%
1/15 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Investigational
n=15 participants at risk
Subjects will be treated with the investigational device and followed per protocol.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Chest pressure
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Abdominal bruising
|
13.3%
2/15 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Achilles tendonitis
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Allergic reaction with blistering on skin
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Groin complication
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Animal Bite
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Immune system disorders
Arthritis flare
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Back pain post-procedure
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion of right thigh
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
General disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Cardiac disorders
Essential hypertension
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
Flu
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Vascular disorders
Indeterminate thrombus
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection at enoxaparin injection site
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Injection site reactions
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
Left Lateral ankle venous ulcer infection
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Leg cramps index leg
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
General disorders
Bleeding at lovenox injection site
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
New venous ulcer
|
6.7%
1/15 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in chest and arms (bilateral)
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral artery stenosis
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedure bleeding at access site
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Posterior left knee soreness
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
Recurrent left ankle ulcer infection
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal stones with hydroureteronephrosis
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Right ankle pain
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Right thumb cyst
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
Right toe cellulitis
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
General disorders
Sore throat
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Cardiac disorders
ST depression
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus Left ear
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Valve Pocket Thrombus (VPT)
|
13.3%
2/15 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
Venous ulcer infection
|
26.7%
4/15 • Number of events 8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Worsening osteoarthritis left knee pain
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
Worsening ulceration relating to infection
|
6.7%
1/15 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place