Trial Outcomes & Findings for Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System (NCT NCT04580160)

Last Updated: 2025-05-15

Results Overview

Freedom from major adverse events (MAEs) at 30 days post index procedure, as adjudicated by the Clinical Events Committee (CEC) or Core Laboratory, including: * Device or procedure-related death * Device or procedure-related bleed at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion of ≥2 units * Device or procedure-related venous injury occurring in the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention * Major amputation of the target limb * Clinically significant pulmonary embolism (PE), confirmed by CT angiography * Stent embolization outside of the target vessel * Presence of new thrombus within the stented segment requiring surgical or endovascular intervention

Recruitment status

COMPLETED

Study phase

Target enrollment

162 participants

Primary outcome timeframe

30 days

Results posted on

2025-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Duo Venous Stent System Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Overall Study STARTED	162
Overall Study COMPLETED	136
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VCSS Pain Score is missing for two subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duo Venous Stent System n=162 Participants Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Age, Continuous	59.4 years STANDARD_DEVIATION 15.8 • n=162 Participants
Sex: Female, Male Female	60 Participants n=162 Participants
Sex: Female, Male Male	102 Participants n=162 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=162 Participants
Race (NIH/OMB) Asian	1 Participants n=162 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=162 Participants
Race (NIH/OMB) Black or African American	15 Participants n=162 Participants
Race (NIH/OMB) White	134 Participants n=162 Participants
Race (NIH/OMB) More than one race	0 Participants n=162 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=162 Participants
BMI	30.1 kg/m^2 STANDARD_DEVIATION 5.7 • n=162 Participants
CEAP Clinical Assessment C0 (No visible or palpable signs of venous disease)	2 Participants n=162 Participants
CEAP Clinical Assessment C1 (Telangiectasia or reticular veins)	1 Participants n=162 Participants
CEAP Clinical Assessment C2 (Varicose veins)	1 Participants n=162 Participants
CEAP Clinical Assessment C2r (Recurrent varicose veins)	0 Participants n=162 Participants
CEAP Clinical Assessment C3 (Edema)	107 Participants n=162 Participants
CEAP Clinical Assessment C4 (Changes in skin and subcutaneous tissue secondary to chronic venous disease)	9 Participants n=162 Participants
CEAP Clinical Assessment C4a (Pigmentation or eczema)	21 Participants n=162 Participants
CEAP Clinical Assessment C4b (Lipodermatosclerosis or atrophie blanche)	3 Participants n=162 Participants
CEAP Clinical Assessment C4c (Corona phlebectatica)	0 Participants n=162 Participants
CEAP Clinical Assessment C5 (Healed)	8 Participants n=162 Participants
CEAP Clinical Assessment C6 (Active venous ulcer)	9 Participants n=162 Participants
CEAP Clinical Assessment C6r (Recurrent active venous ulcer)	1 Participants n=162 Participants
VCSS Pain 0 - none	11 Participants n=160 Participants • VCSS Pain Score is missing for two subjects.
VCSS Pain 1 - mild (occasional, not restricting activity or requiring analgesics)	24 Participants n=160 Participants • VCSS Pain Score is missing for two subjects.
VCSS Pain 2 - moderate (daily, moderate activity limitation, occasional analgesics)	84 Participants n=160 Participants • VCSS Pain Score is missing for two subjects.
VCSS Pain 3 - severe (daily, severe limiting activities or requiring regular use of analgesics)	41 Participants n=160 Participants • VCSS Pain Score is missing for two subjects.

PRIMARY outcome

Timeframe: 30 days

Population: The number of evaluable subjects for the 30 day Primacy Safety Endpoint was 159.

Outcome measures

Outcome measures
Measure	Duo Venous Stent System n=159 Participants Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.	DUO Venous Stent System VCSS Pain Score at 12 months
Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days	157 Participants	—

PRIMARY outcome

Timeframe: 12 months

Population: Of the 136 subjects that completed 12-month follow-up, 132 had data evaluable for the 12-month primary efficacy endpoint. The four subjects in question did not complete the 12-month DUS or had a non-diagnostic 12-month DUS.

Primary patency of stented segment at 12 months defined as freedom from: * Duplex Ultrasound (DUS) core laboratory adjudicated occlusion or stenosis \>50% within the stented segment. If DUS shows \>50% stenosis or occlusion, confirmation by diagnostic intravascular ultrasound (IVUS) is required. * CEC adjudicated clinically driven target lesion reintervention (CD-TLR) defined as endovascular or surgical procedure for new, recurrent, or worsening symptoms and core lab adjudicated \>50% stenosis or occlusion within the stented segment confirmed by diagnostic IVUS

Outcome measures

Outcome measures
Measure	Duo Venous Stent System n=132 Participants Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.	DUO Venous Stent System VCSS Pain Score at 12 months
Efficacy - Number of Participants With Primary Patency of Stented Segment at 12 Months	119 Participants	—

SECONDARY outcome

Timeframe: 12 months

Population: Although 136 subjects completed 12-month follow-up, two additional subjects completed 12-month telephone visits during which VCSS data was collected.

The Venous Clinical Severity Score (VCSS) system is a scoring system used to categorize nine attributes of venous disease. For this study, only the Pain Score was collected. The levels of pain severity ranged from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Duo Venous Stent System n=160 Participants Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.	DUO Venous Stent System n=138 Participants VCSS Pain Score at 12 months
VCSS Pain Score and Changes in VCSS From Baseline in ITT Patients	2.0 score on a scale Standard Deviation 0.8	0.5 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 months

Population: Primary Assisted Patency data is missing for 5/136 subjects that completed 12-month follow-up.

Primary assisted patency is defined as freedom from DUS core laboratory adjudicated occlusion or stenosis \>50% within the stented segment following a reintervention due to a \>50% but \<100% stenosis. If DUS shows \>50% stenosis or occlusion, confirmation by diagnostic IVUS is required.

Outcome measures

Outcome measures
Measure	Duo Venous Stent System n=131 Participants Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.	DUO Venous Stent System VCSS Pain Score at 12 months
Number of ITT Subjects With Primary Assisted Patency at 12 Months	124 Participants	—

SECONDARY outcome

Timeframe: 12 months

Population: Secondary Patency data is missing for 5/136 subjects that completed 12-month follow-up.

Secondary patency at 12 months defined as freedom from DUS core laboratory adjudicated occlusion or stenosis \>50% within the stented segment following a reintervention due to 100% occlusion. If DUS shows \>50% stenosis or occlusion, confirmation by diagnostic IVUS is required.

Outcome measures

Outcome measures
Measure	Duo Venous Stent System n=131 Participants Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.	DUO Venous Stent System VCSS Pain Score at 12 months
Number of ITT Subjects With Secondary Patency at 12 Months	125 Participants	—

Adverse Events

Duo Venous Stent System

Serious events: 46 serious events

Other events: 102 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Duo Venous Stent System n=162 participants at risk Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Cardiac disorders Cardiac Disorders	3.1% 5/162 • Number of events 6 • Summary of adverse events that have been reported through 390 days
Congenital, familial and genetic disorders Congenital, familial and genetic disorders	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Gastrointestinal disorders Gastrointestinal disorders	3.1% 5/162 • Number of events 5 • Summary of adverse events that have been reported through 390 days
General disorders General disorders and administration site conditions	4.3% 7/162 • Number of events 7 • Summary of adverse events that have been reported through 390 days
Infections and infestations Infections and infestations	4.9% 8/162 • Number of events 9 • Summary of adverse events that have been reported through 390 days
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	2.5% 4/162 • Number of events 4 • Summary of adverse events that have been reported through 390 days
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.62% 1/162 • Number of events 2 • Summary of adverse events that have been reported through 390 days
Nervous system disorders Nervous system disorders	1.9% 3/162 • Number of events 5 • Summary of adverse events that have been reported through 390 days
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Product Issues Product issues	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Psychiatric disorders Psychiatric disorders	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Renal and urinary disorders Renal and urinary disorders	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Reproductive system and breast disorders Reproductive system and breast disorders	1.9% 3/162 • Number of events 3 • Summary of adverse events that have been reported through 390 days
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Surgical and medical procedures Surgical and medical procedures	1.2% 2/162 • Number of events 3 • Summary of adverse events that have been reported through 390 days
Vascular disorders Vascular disorders	5.6% 9/162 • Number of events 11 • Summary of adverse events that have been reported through 390 days

Other adverse events

Other adverse events
Measure	Duo Venous Stent System n=162 participants at risk Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Blood and lymphatic system disorders Blood and lymphatic system disorders	3.1% 5/162 • Number of events 6 • Summary of adverse events that have been reported through 390 days
Cardiac disorders Cardiac disorders	7.4% 12/162 • Number of events 17 • Summary of adverse events that have been reported through 390 days
Congenital, familial and genetic disorders Congenital, familial and genetic disorders	1.2% 2/162 • Number of events 3 • Summary of adverse events that have been reported through 390 days
Ear and labyrinth disorders Ear and labyrinth disorders	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Gastrointestinal disorders Gastrointestinal disorders	11.7% 19/162 • Number of events 22 • Summary of adverse events that have been reported through 390 days
General disorders General disorders and administration site conditions	19.1% 31/162 • Number of events 44 • Summary of adverse events that have been reported through 390 days
Immune system disorders Immune system disorders	1.2% 2/162 • Number of events 2 • Summary of adverse events that have been reported through 390 days
Infections and infestations Infections and infestations	24.1% 39/162 • Number of events 51 • Summary of adverse events that have been reported through 390 days
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	8.0% 13/162 • Number of events 14 • Summary of adverse events that have been reported through 390 days
Investigations Investigations	1.2% 2/162 • Number of events 2 • Summary of adverse events that have been reported through 390 days
Metabolism and nutrition disorders Metabolism and nutrition disorders	1.2% 2/162 • Number of events 2 • Summary of adverse events that have been reported through 390 days
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	19.8% 32/162 • Number of events 47 • Summary of adverse events that have been reported through 390 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1.2% 2/162 • Number of events 2 • Summary of adverse events that have been reported through 390 days
Nervous system disorders Nervous system disorders	9.9% 16/162 • Number of events 23 • Summary of adverse events that have been reported through 390 days
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Product Issues Product issues	0.62% 1/162 • Number of events 1 • Summary of adverse events that have been reported through 390 days
Psychiatric disorders Psychiatric disorders	1.2% 2/162 • Number of events 2 • Summary of adverse events that have been reported through 390 days
Renal and urinary disorders Renal and urinary disorders	2.5% 4/162 • Number of events 5 • Summary of adverse events that have been reported through 390 days
Reproductive system and breast disorders Reproductive system and breast disorders	2.5% 4/162 • Number of events 5 • Summary of adverse events that have been reported through 390 days
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	8.0% 13/162 • Number of events 17 • Summary of adverse events that have been reported through 390 days
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	6.2% 10/162 • Number of events 14 • Summary of adverse events that have been reported through 390 days
Surgical and medical procedures Surgical and medical procedures	1.9% 3/162 • Number of events 4 • Summary of adverse events that have been reported through 390 days
Vascular disorders Vascular disorders	16.7% 27/162 • Number of events 33 • Summary of adverse events that have been reported through 390 days

Additional Information

Joseph C. Griffin, III

Vesper Medical

Phone: 4848926340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place