NCT04580160: VIVID

Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System

Completed NA Results posted Last updated 15 May 2025

What this trial tests

NA trial testing Duo Venous Stent System in May-Thurner Syndrome in 162 participants. Completed in 15 April 2025.

Timeline

30 November 2020

Primary endpoint
3 December 2022

15 April 2025

Quick facts

Lead sponsor	Vesper Medical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	162
Start date	30 November 2020
Primary completion	3 December 2022
Estimated completion	15 April 2025
Sites	30 locations across United States, Poland

Drugs / interventions tested

• Duo Venous Stent System

Conditions studied

• May-Thurner Syndrome — all drugs for May-Thurner Syndrome →
• Deep Vein Thrombosis — all drugs for Deep Vein Thrombosis →
• Chronic Venous Insufficiency — all drugs for Chronic Venous Insufficiency →

Sponsor

Vesper Medical, Inc.

Who can join

18 and older, any sex, with May-Thurner Syndrome or Deep Vein Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days Primary · 30 days

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 * Clinicall

Group	Value	95% CI
Duo Venous Stent System	157

Efficacy - Number of Participants With Primary Patency of Stented Segment at 12 Months Primary · 12 months

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

Group	Value	95% CI
Duo Venous Stent System	119

VCSS Pain Score and Changes in VCSS From Baseline in ITT Patients Secondary · 12 months

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).

Group	Value	95% CI
Duo Venous Stent System	2.0	± 0.8
DUO Venous Stent System	0.5	± 0.8

Number of ITT Subjects With Primary Assisted Patency at 12 Months Secondary · 12 months

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.

Group	Value	95% CI
Duo Venous Stent System	124

Number of ITT Subjects With Secondary Patency at 12 Months Secondary · 12 months

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.

Group	Value	95% CI
Duo Venous Stent System	125

Adverse events — posted to ClinicalTrials.gov

Time frame: Summary of adverse events that have been reported through 390 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Duo Venous Stent System

Serious: 46/162 (28%)

Deaths: 2/162

Serious adverse events (18 terms)

Reaction	System	Duo Venous Stent System
Vascular disorders	Vascular disorders	—
Infections and infestations	Infections and infestations	—
General disorders and administration site conditions	General disorders	—
Cardiac Disorders	Cardiac disorders	—
Gastrointestinal disorders	Gastrointestinal disorders	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—
Nervous system disorders	Nervous system disorders	—
Reproductive system and breast disorders	Reproductive system and breast disorders	—
Surgical and medical procedures	Surgical and medical procedures	—
Blood and lymphatic system disorders	Blood and lymphatic system disorders	—
Congenital, familial and genetic disorders	Congenital, familial and genetic disorders	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	—
Pregnancy, puerperium and perinatal conditions	Pregnancy, puerperium and perinatal conditions	—
Product issues	Product Issues	—
Psychiatric disorders	Psychiatric disorders	—
Renal and urinary disorders	Renal and urinary disorders	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—

Other adverse events (23 terms — click to expand)

Reaction	System	Duo Venous Stent System
Infections and infestations	Infections and infestations	—
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	—
General disorders and administration site conditions	General disorders	—
Vascular disorders	Vascular disorders	—
Gastrointestinal disorders	Gastrointestinal disorders	—
Nervous system disorders	Nervous system disorders	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—
Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	—
Cardiac disorders	Cardiac disorders	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—
Blood and lymphatic system disorders	Blood and lymphatic system disorders	—
Renal and urinary disorders	Renal and urinary disorders	—
Reproductive system and breast disorders	Reproductive system and breast disorders	—
Surgical and medical procedures	Surgical and medical procedures	—
Congenital, familial and genetic disorders	Congenital, familial and genetic disorders	—
Immune system disorders	Immune system disorders	—
Investigations	Investigations	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Psychiatric disorders	Psychiatric disorders	—
Ear and labyrinth disorders	Ear and labyrinth disorders	—
Pregnancy, puerperium and perinatal conditions	Pregnancy, puerperium and perinatal conditions	—
Product issues	Product Issues	—

Most-reported serious reactions: Vascular disorders, Infections and infestations, General disorders and administration site conditions, Cardiac Disorders, Gastrointestinal disorders, Injury, poisoning and procedural complications, Nervous system disorders, Reproductive system and breast disorders.

Data from ClinicalTrials.gov NCT04580160 adverse events section.

Sponsor's own description

This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to investigate the safety and efficacy of the Vesper DUO Venous Stent System as compared to a pre-defined performance goal (PG) established from published, peer reviewed scientific literature related to stenting of iliofemoral venous outflow obstructions.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The VIVID trial 12-month outcomes of the venous stent for the iliofemoral vein using the Duo venous stent system.
   Razavi M, Lichtenberg M, Desai K, Dexter D, et al · · 2025 · cited 5× · PMID 39477150 · DOI 10.1016/j.jvsv.2024.101995