Great Saphenous Vein (GSV) With Venous Reflux DiseaseVeCloseNCT01807585
VenaSeal Sapheon Closure System Pivotal Study (VeClose)
A study testing VenaSeal SCS, ClosureFast Radiofrequency Ablation (RFA) and Roll-in (VenaSeal SCS) in people with Great Saphenous Vein (GSV) With Venous Reflux Disease, run by Medtronic Endovascular at 10 sites in United States.
Trial summary
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Great Saphenous Vein (GSV) With Venous Reflux Disease
- What is being tested?
- VenaSeal SCS, ClosureFast Radiofrequency Ablation (RFA) and Roll-in (VenaSeal SCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2013to 10 Apr 2017
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years and ≤ 70 years of age at the time of screening
- Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux
- One or more of the following symptoms related to the target vein: aching, throbbing, heaviness, fatigue, pruritis, night cramps, restlessness, generalized pain or discomfort, swelling
- GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound
- Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b
- Ability to walk unassisted
- Ability to attend follow-up visits
- Ability to understand the requirements of the study and to provide informed consent
Who cannot join
- Life expectancy < 1 year
- Active treatment for malignancy other than non-melanoma skin cancer
- Symptomatic peripheral arterial disease with ankle-brachial index (ABI) <0.89
- Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux
- Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
- Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE)
Show all 19Show fewer
- Previous superficial thrombophlebitis in GSV
- Previous treatment of venous disease in target limb, other than spider vein treatment
- Known hypercoagulable disorder
- Conditions which prevent vein treatment with either RFA or VenaSeal SCS
- Immobilization or inability to ambulate
- Pregnant prior to enrollment
- Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site
- Aneurysm of the target vein with local diameter >12 mm
- Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s)
- Known sensitivity to cyanoacrylate (CA) adhesives
- Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment
- Patients who require bilateral treatment during the next 3 months
- Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Lake Washington Vascular
Bellevue, Washington, 98004-4623
Inovia Vein Specialty Center
Bend, Oregon, 97701
Radiology Imaging Associates (RIA)
Greenwood Village, Colorado, 80111
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, 21030
Vein Institute of Buffalo
North Tonawanda, New York, 14120
Vein Clinics of America
Oakbrook Terrace, Illinois, 60181
GBK Cosmetic Laser Dermatology
San Diego, California, 92121
Morrison Vein Institute
Scottsdale, Arizona, 85255
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
Sentara Vascular Specialist
Virginia Beach, Virginia, 23452
About this study
Official title: VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.
Read the detailed description
The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal SCS as being both 1) non-inferior to RFA therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the reduction of intraprocedural and post procedural pain and symptoms as compared to treatment with RFA.
The study was designed to demonstrate safety of the VenaSeal SCS by follow-up visits that evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis and/or pulmonary embolus.
- Being tested
- VenaSeal SCS, ClosureFast Radiofrequency Ablation (RFA), Roll-in (VenaSeal SCS)
- Keywords
- GSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenaSeal SCSDevice
Also called VenaSeal Sapheon Closure System, VSCS
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
ClosureFast Radiofrequency Ablation (RFA)Device
Also called ClosureFast
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
Roll-in (VenaSeal SCS)Device
Also called VenaSeal Sapheon Closure System, VSCS, Roll-in
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
| Study group | Role | What they receive |
|---|---|---|
| VenaSeal SCS | Experimental | Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA. Receives: Device: VenaSeal SCS |
| RFA (ClosureFast) | Active comparator | Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Heat is applied to the target vein using radiofrequency energy to ablate the target vein. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or RFA. Receives: Device: ClosureFast Radiofrequency Ablation (RFA) |
| Roll-in (VenaSeal SCS) | Experimental | Prior to initiation of the randomized cohort at each site, a non-randomized cohort of 2 subjects per clinical site (roll-in phase) were enrolled and treated with VenalSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Receives: Device: Roll-in (VenaSeal SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Closure of the Target Vein at 3 Months
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Measured: 3 months
Secondary outcomes (2)
Intraoperative Pain
After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.
Measured: During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.
Ecchymosis at Day 3
At the Day 3 visit, the investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome.
The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site.
The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria:
0 rating = no ecchymosis,
- rating = less than 25% ecchymosis,
- rating = 25-50% ecchymosis,
- rating = 50-75% ecchymosis,
- rating = 75-100% ecchymosis,
- rating = extension of ecchymosis above or below the treated area.
Measured: First follow up visit at day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completion10 Apr 2017
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Great Saphenous Vein (GSV) With Venous Reflux DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sapheon, Inc.
- Responsible party
- Sponsor
- Investigators
- Nick Morrison, MD, Principal investigator, Morrison Vein Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807585
- Sponsor's protocol ID
- CP-11101-01
- Acronym
- VeClose
- Status last verified
- May 2018
- First submitted
- 5 Mar 2013
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
PubMed 28411697Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.
PubMed 27638993Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15.
PubMed 29914814Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
PubMed 25650040
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins
- ClinicalTrials.gov ID
- NCT01807585
- Acronym / sponsor ID
- VeClose / CP-11101-01
- Keywords
- GSV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Collaborators
- Sapheon, Inc.
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 26 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.
Detailed description
The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal SCS as being both 1) non-inferior to RFA therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the reduction of intraprocedural and post procedural pain and symptoms as compared to treatment with RFA.
The study was designed to demonstrate safety of the VenaSeal SCS by follow-up visits that evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis and/or pulmonary embolus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VenaSeal SCS | Experimental | Device: VenaSeal SCSEndovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA. |
| RFA (ClosureFast) | Active comparator | Device: ClosureFast Radiofrequency Ablation (RFA)Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Heat is applied to the target vein using radiofrequency energy to ablate the target vein. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or RFA. |
| Roll-in (VenaSeal SCS) | Experimental | Device: Roll-in (VenaSeal SCS)Prior to initiation of the randomized cohort at each site, a non-randomized cohort of 2 subjects per clinical site (roll-in phase) were enrolled and treated with VenalSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 21 years and ≤ 70 years of age at the time of screening
- Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux
- One or more of the following symptoms related to the target vein: aching, throbbing, heaviness, fatigue, pruritis, night cramps, restlessness, generalized pain or discomfort, swelling
- GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound
- Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b
Key exclusion criteria (19 listed)
- Life expectancy < 1 year
- Active treatment for malignancy other than non-melanoma skin cancer
- Symptomatic peripheral arterial disease with ankle-brachial index (ABI) <0.89
- Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux
- Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
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 |
|---|---|---|
| VenaSeal SCSAlso: VenaSeal Sapheon Closure System, VSCSNon-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein. | Device | VenaSeal SCS |
| ClosureFast Radiofrequency Ablation (RFA)Also: ClosureFastRadiofrequency thermal ablation of the GSV using the Covidien ClosureFast system. | Device | RFA (ClosureFast) |
| Roll-in (VenaSeal SCS)Also: VenaSeal Sapheon Closure System, VSCS, Roll-inNon-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein. | Device | Roll-in (VenaSeal SCS) |
Primary outcome
Number of Participants With Complete Closure of the Target Vein at 3 Months
Time frame: 3 months
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
2 secondary outcomes
Intraoperative Pain
Time frame: During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.
Ecchymosis at Day 3
Time frame: First follow up visit at day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28411697Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
- Results publication: PubMed 27638993Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.
- Derived from this study: PubMed 29914814Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15.
- Derived from this study: PubMed 25650040Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
- Individual participant dataSharing planned: No
Related trials for Great Saphenous Vein (GSV) With Venous Reflux Disease
Active, not recruitingPhase 3
Endovenous Laser Ablation With 1940 nm Versus 1470 nm
Varicose Veins of Lower Limb, Great Saphenous Vein (GSV) With Venous Reflux Disease
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.
Nick Morrison, MD principal investigator
Morrison Vein Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VenaSeal SCS, ClosureFast Radiofrequency Ablation (RFA) and Roll-in (VenaSeal SCS) in people with Great Saphenous Vein (GSV) With Venous Reflux Disease, run by Medtronic Endovascular at 10 sites in United States.
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 8 inclusion and 19 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: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2018). 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?
Number of Participants With Complete Closure of the Target Vein at 3 Months (time frame: 3 months). 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 NCT01807585, which also lists 4 linked publications.
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 26 Jun 2018.