Venous RefluxNCT00842296

ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

A study testing RF ablation (ClosureFAST) in people with Venous Reflux, run by Medtronic Endovascular.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Venous Reflux
What is being tested?: RF ablation (ClosureFAST)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 326 participants
Where: No sites listed yet
Study dates: Apr 2006to May 2012
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18 and 80 years of age at the time of enrollment
Symptomatic lower limb venous disease involving the GSV

Who cannot join

Thrombosis in the vein segment to be treated
Known or suspected pregnancy or actively breast feeding at time of treatment

About this study

Official title: ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

Read the detailed description

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.

Conditions: Venous Reflux
Being tested: RF ablation (ClosureFAST)
Keywords: GSV, RadioFrequency

What participants receive

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

RF ablation (ClosureFAST)Device
Also called CLF, CLosureFAST
Segmental RF Ablation with the CLF catheter

Study groups in NCT00842296
Study group	Role	What they receive
Seg. RF Ablation with CLF catheter	Experimental	Single Arm with CLF Catheter Receives: Device: RF ablation (ClosureFAST)

What is being measured

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

Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure.
Measured: 6 Months
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Measured: 12 months
Percentage of Limbs Without Vein Occlusion
Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan.
Measured: 2 years
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Measured: 3 years
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Measured: 4 years
Percentage of Limbs Without Vein Occlusion
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Measured: 5 years
Percentage of Limbs Without Reflux in the Treated Vein Segment
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Measured: 6 months
Percentage of Limbs Without Reflux in the Treated Vein Segment
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Measured: 12 months
Percentage of Limbs Without Reflux in the Treated Vein Segment
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Measured: 2 years
Percentage of Limbs Without Reflux in the Treated Vein Segment
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Measured: 3 years
Percentage of Limbs Without Reflux in the Treated Vein Segment
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Measured: 4 years
Percentage of Limbs Without Reflux in the Treated Vein Segment
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Measured: 5 years

Secondary outcomes (11)

CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification
Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration
Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The "CEAP" classification. Mayo Clinic Proc 1996;71:338-45.
Measured: Baseline
CEAP Classification
Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.
Measured: 1 Week
CEAP Classification
Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.
Measured: 3 months
CEAP Classification
Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.
Measured: 12 months
CEAP Classification
Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.
Measured: 5 years
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up
Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0).
Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12.
Measured: Baseline thru 5 years
Visual Analog Pain Scale (VAS)
Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain
Measured: 5 years
Presence of Complications From Greater Saphenous Vein (GSV) Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Measured: 1 Week
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Measured: 3 Months
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Measured: 12 months
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Measured: 5 years

Timeline

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

Apr 2006May 2012

First posted12 Feb 2009 (estimated)
Study startApr 2006
Primary completionMay 2012
Study completionMay 2012

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 (1)Papers the sponsor has linked to this study.
Other trials for Venous RefluxStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00842296
Sponsor's protocol ID: CLF-05-03
Status last verified: Feb 2018
First submitted: 10 Feb 2009
Last updated: 12 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Publications

Proebstle TM, Mohler T. A longitudinal single-center cohort study on the prevalence and risk of accessory saphenous vein reflux after radiofrequency segmental thermal ablation of great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):265-9. doi: 10.1016/j.jvsv.2014.10.001. Epub 2014 Dec 6.
PubMed 26992304

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?

Official record

Active, not recruiting
Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
Vascular Access Devices, Catheters
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
RecruitingObservational study
HEMOVAR Study on Hemorrhoids and Varicose Veins
Varicose Veins of Lower Limb, Hemorrhoids
Active, not recruiting
Venclose digiRF System Post Market Study
Venous Reflux, Chronic Venous Insufficiency
Recruiting
The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
Varicose Veins, Chronic Venous Insufficiency

All Venous Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element
ClinicalTrials.gov ID: NCT00842296
Acronym / sponsor ID: CLF-05-03
Conditions: Venous Reflux
Keywords: GSV, RadioFrequency
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 12 Feb 2009 (estimated)
Results: Posted 11 Dec 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Seg. RF Ablation with CLF catheter	Experimental	Device: RF ablation (ClosureFAST)Single Arm with CLF Catheter

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age between 18 and 80 years of age at the time of enrollment
Symptomatic lower limb venous disease involving the GSV

Key exclusion criteria (2 listed)

Thrombosis in the vein segment to be treated
Known or suspected pregnancy or actively breast feeding at time of treatment

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
RF ablation (ClosureFAST)Also: CLF, CLosureFASTSegmental RF Ablation with the CLF catheter	Device	Seg. RF Ablation with CLF catheter

Primary outcome

Percentage of Limbs Without Vein Occlusion
Time frame: 6 Months
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure.
Percentage of Limbs Without Vein Occlusion
Time frame: 12 months
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Percentage of Limbs Without Vein Occlusion
Time frame: 2 years
Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan.
Percentage of Limbs Without Vein Occlusion
Time frame: 3 years
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Percentage of Limbs Without Vein Occlusion
Time frame: 4 years
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Percentage of Limbs Without Vein Occlusion
Time frame: 5 years
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.
Percentage of Limbs Without Reflux in the Treated Vein Segment
Time frame: 6 months
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Percentage of Limbs Without Reflux in the Treated Vein Segment
Time frame: 12 months
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Percentage of Limbs Without Reflux in the Treated Vein Segment
Time frame: 2 years
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Percentage of Limbs Without Reflux in the Treated Vein Segment
Time frame: 3 years
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Percentage of Limbs Without Reflux in the Treated Vein Segment
Time frame: 4 years
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
Percentage of Limbs Without Reflux in the Treated Vein Segment
Time frame: 5 years
No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

11 secondary outcomes

CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification
Time frame: Baseline
CEAP Classification
Time frame: 1 Week
CEAP Classification
Time frame: 3 months
CEAP Classification
Time frame: 12 months
CEAP Classification
Time frame: 5 years
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up
Time frame: Baseline thru 5 years
Visual Analog Pain Scale (VAS)
Time frame: 5 years
Presence of Complications From Greater Saphenous Vein (GSV) Intervention
Time frame: 1 Week
Presence of Complications From GSV Intervention
Time frame: 3 Months
Presence of Complications From GSV Intervention
Time frame: 12 months
Presence of Complications From GSV Intervention
Time frame: 5 years

Results and safety

Results posted to the registry on 11 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei	326	326

Primary outcome: Percentage of Limbs Without Vein Occlusion

Time frame: 6 Months. Mean (Standard Error). Unit: percentage of limbs

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n = 293
Value	97.6 (0.8)

Population analysed: 363 limbs were available for primary outcome measure evaluation at the 6M timepoint.

Primary outcome: Percentage of Limbs Without Vein Occlusion

Time frame: 12 months. Mean (Standard Error). Unit: percentage of limbs

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n = 280
Value	96.6 (0.9)

Population analysed: 350 limbs were evaluated at the 12M timepoint

Primary outcome: Percentage of Limbs Without Vein Occlusion

Time frame: 2 years. Mean (Standard Error). Unit: percentage of limbs

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n = 263
Value	94.3 (1.2)

Population analysed: Out of the limbs treated 329 limbs were available for a Duplex Ultrasound scan at the 2Y follow-up

Primary outcome: Percentage of Limbs Without Vein Occlusion

Time frame: 3 years. Mean (Standard Error). Unit: percentage of limbs

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n = 229
Value	92.8 (1.4)

Population analysed: 293 limbs were evaluated at the 3Y timepoint

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei	10 of 326 (3.1%)	0 of 326 (0%)	2 of 326

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26992304Proebstle TM, Mohler T. A longitudinal single-center cohort study on the prevalence and risk of accessory saphenous vein reflux after radiofrequency segmental thermal ablation of great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):265-9. doi: 10.1016/j.jvsv.2014.10.001. Epub 2014 Dec 6.
Individual participant dataSharing planned: Yes

Related trials for Venous Reflux

Active, not recruiting
Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
Vascular Access Devices, Catheters
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
RecruitingObservational study
HEMOVAR Study on Hemorrhoids and Varicose Veins
Varicose Veins of Lower Limb, Hemorrhoids
Active, not recruiting
Venclose digiRF System Post Market Study
Venous Reflux, Chronic Venous Insufficiency
Recruiting
The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
Varicose Veins, Chronic Venous Insufficiency

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.

Melissa Hasenbank, PhD study director

Medtronic

Questions about this trial

What is this clinical trial studying?

A study testing RF ablation (ClosureFAST) in people with Venous Reflux, run by Medtronic Endovascular.

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 2 inclusion and 2 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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 11 Dec 2017). 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?

Percentage of Limbs Without Vein Occlusion (time frame: 6 Months). The study lists 12 primary outcomes in all. 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 NCT00842296, which also lists 1 linked publication.

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 12 Mar 2018.