Venous InsufficiencyPhase 2VICARESNCT03311269

A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency

A Phase 2 study testing ClariVein RES, Sodium Tetradecyl Sulfate 1% Injection and Sodium Tetradecyl Sulfate 3% Injection in people with Venous Insufficiency, run by Vascular Insights, LLC at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

VICARES is a prospective randomized, controlled, multi-center, double blind study treating venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium Tetradecyl Sulfate (STS) solution utilizing the ClariVein system. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Venous Insufficiency
What is being tested?: ClariVein RES, Sodium Tetradecyl Sulfate 1% Injection and Sodium Tetradecyl Sulfate 3% Injection
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 5 sitesUnited States
Study dates: 22 Sep 2017to 27 Mar 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult patient with incompetent saphenous vein
Saphenous vein reflux > 500ms (0.5s), as measured by duplex ultrasound
One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.
Candidate for endovenous procedure

Who cannot join

Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings
Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) <0.6
Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity
Previous surgical or endovenous procedure in the treatment section of the target vein
Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section
Pregnant or breastfeeding

Show all 10Show fewer

Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)
Known high risk of thrombosis
Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of acute superficial vein thrombus, known hypercoagulable condition, post thrombotic syndrome
Known history of anaphylaxis or presence of multiple severe allergies

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Lake Washington Vascular, PLLC
Bellevue, Washington, 98004
The Vascular Experts
Darien, Connecticut, 06820
Englegwood Hospital and Medical Center
Englewood, New Jersey, 07631
Capitol Vein and Laser Centers
Frederick, Maryland, 21702
Southeastern Surgical Associates
Hyannis, Massachusetts, 02601

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled, Multi-Center, Double Blind Study of ClariVein RES for Treatment of Venous Insufficiency Associated With Incompetent Saphenous Veins Due to Superficial Venous Reflux

Read the detailed description

Approximately 50 subjects diagnosed with an incompetent saphenous vein will be randomized to either 1% STS or 3% STS solution delivered by the ClariVein system under ultrasound guidance.

Study duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.

Conditions: Venous Insufficiency
Being tested: ClariVein RES, Sodium Tetradecyl Sulfate 1% Injection, Sodium Tetradecyl Sulfate 3% Injection
Medical subject headings: Venous Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClariVein RESDevice
ClariVein system
Sodium Tetradecyl Sulfate 1% InjectionDrug
Also called STS 1%
Sodium Tetradecyl Sulfate STS 1% Injection
Sodium Tetradecyl Sulfate 3% InjectionDrug
Also called STS 3%
Sodium Tetradecyl Sulfate 3% Injection

Study groups in NCT03311269
Study group	Role	What they receive
ClariVein RES 1% Injection	Active comparator	Sodium Tetradecyl Sulfate 1% Injection single administration Receives: Device: ClariVein RES; Drug: Sodium Tetradecyl Sulfate 1% Injection
ClariVein RES 3% Injection	Active comparator	Sodium Tetradecyl Sulfate 3% Injection single administration Receives: Device: ClariVein RES; Drug: Sodium Tetradecyl Sulfate 3% Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.
The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, \& a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing \& Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study.
Measured: 12 weeks

Secondary outcomes (1)

Elimination of Saphenous Vein Reflux
Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein > 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow > 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 201727 Mar 2020

First posted17 Oct 2017
Study start22 Sep 2017
Primary completion15 May 2018
Study completion27 Mar 2020

Why it stopped: Study was terminated for administrative reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03311269
Sponsor's protocol ID: CL-001
Acronym: VICARES
Status last verified: Feb 2022
First submitted: 11 Oct 2017
Last updated: 2 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
Recruiting
Pilot Study: Evaluation of the Safety of the Application of Non-thermal HIFU for Varicose Veins Treatment of the Lower Limbs
Superficial Venous Insufficiency, Varicose Veins

All Venous Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Multi-Center, Double Blind Study of ClariVein RES for Treatment of Venous Insufficiency Associated With Incompetent Saphenous Veins Due to Superficial Venous Reflux
ClinicalTrials.gov ID: NCT03311269
Acronym / sponsor ID: VICARES / CL-001
Conditions: Venous Insufficiency
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated for administrative reasons
Enrolment: 19 participants (actual)
Lead sponsor: Vascular Insights, LLCIndustry (pharma, biotech, devices)
Study start: 22 Sep 2017 (actual)
Primary completion: 15 May 2018 (actual)
Study completion: 27 Mar 2020 (actual)
First posted: 17 Oct 2017 (actual)
Results: Posted 2 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 50 subjects diagnosed with an incompetent saphenous vein will be randomized to either 1% STS or 3% STS solution delivered by the ClariVein system under ultrasound guidance.

Study duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ClariVein RES 1% Injection	Active comparator	Device: ClariVein RES, Drug: Sodium Tetradecyl Sulfate 1% InjectionSodium Tetradecyl Sulfate 1% Injection single administration
ClariVein RES 3% Injection	Active comparator	Device: ClariVein RES, Drug: Sodium Tetradecyl Sulfate 3% InjectionSodium Tetradecyl Sulfate 3% Injection single administration

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patient with incompetent saphenous vein
Saphenous vein reflux > 500ms (0.5s), as measured by duplex ultrasound
One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.
Candidate for endovenous procedure

Key exclusion criteria (10 listed)

Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings
Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) <0.6
Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity
Previous surgical or endovenous procedure in the treatment section of the target vein
Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClariVein RESClariVein system	Device	ClariVein RES 1% Injection, ClariVein RES 3% Injection
Sodium Tetradecyl Sulfate 1% InjectionAlso: STS 1%Sodium Tetradecyl Sulfate STS 1% Injection	Drug	ClariVein RES 1% Injection
Sodium Tetradecyl Sulfate 3% InjectionAlso: STS 3%Sodium Tetradecyl Sulfate 3% Injection	Drug	ClariVein RES 3% Injection

Primary outcome

Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.
Time frame: 12 weeks
The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, \& a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing \& Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study.

1 secondary outcome

Elimination of Saphenous Vein Reflux
Time frame: 12 weeks

Results and safety

Results posted to the registry on 2 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ClariVein RES 1% Injection	10	10
ClariVein RES 3% Injection	9	9

Primary outcome: Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.

Time frame: 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	ClariVein RES 1% Injection n = 10	ClariVein RES 3% Injection n = 9
Value	7.2 (3.00)	6.2 (1.87)

ClariVein RES 1% Injection vs ClariVein RES 3% Injection: Mean Difference (Final Values): -4.2 (95% CI -6.2 to -2.3), p <0.001, t-test, 2 sided
ClariVein RES 1% Injection: Mean Difference (Final Values): -3.4 (95% CI -5.8 to -1.0), p = 0.011, t-test, 2 sided
ClariVein RES 3% Injection: Mean Difference (Final Values): -5.1 (95% CI -8.7 to -1.6), p = 0.010, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ClariVein RES 1% Injection	0 of 10 (0%)	1 of 10 (10%)	0 of 10
ClariVein RES 3% Injection	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9

Limitations and caveats (from the sponsor): A total of 19 subjects were enrolled in the study. The study was terminated for administrative reasons; there were no safety or efficacy concerns. It was determined by the sponsor that the Phase 3 protocol, which is designed to closely mimic the Phase 2 protocol, would be adequate to collect safety and efficacy assessments with minor adjustments.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Venous Insufficiency

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
Recruiting
Pilot Study: Evaluation of the Safety of the Application of Non-thermal HIFU for Varicose Veins Treatment of the Lower Limbs
Superficial Venous Insufficiency, Varicose Veins

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark H Meissner, MD study chair

Vascular and Endovascular Surgery Clinic at UWMC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.