ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
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ClinicalTrials.gov Identifier: NCT00842296 |
Recruitment Status :
Completed
First Posted : February 12, 2009
Results First Posted : December 11, 2017
Last Update Posted : March 12, 2018
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Condition or disease | Intervention/treatment | Phase |
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Venous Reflux | Device: RF ablation (ClosureFAST) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 326 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
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Experimental: Seg. RF Ablation with CLF catheter
Single Arm with CLF Catheter
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Device: RF ablation (ClosureFAST)
Segmental RF Ablation with the CLF catheter
Other Names:
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- 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.
- CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification [ Time Frame: Baseline ]
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.
- CEAP Classification [ Time Frame: 1 Week ]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.
- CEAP Classification [ Time Frame: 3 months ]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.
- CEAP Classification [ Time Frame: 12 months ]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.
- CEAP Classification [ Time Frame: 5 years ]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.
- Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up [ Time Frame: Baseline thru 5 years ]
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.
- Visual Analog Pain Scale (VAS) [ Time Frame: 5 years ]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
- Presence of Complications From Greater Saphenous Vein (GSV) Intervention [ Time Frame: 1 Week ]Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
- Presence of Complications From GSV Intervention [ Time Frame: 3 Months ]Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
- Presence of Complications From GSV Intervention [ Time Frame: 12 months ]Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
- Presence of Complications From GSV Intervention [ Time Frame: 5 years ]Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 80 years of age at the time of enrollment
- Symptomatic lower limb venous disease involving the GSV
Exclusion Criteria:
- Thrombosis in the vein segment to be treated
- Known or suspected pregnancy or actively breast feeding at time of treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842296
Study Director: | Melissa Hasenbank, PhD | Medtronic |
Responsible Party: | Medtronic Endovascular |
ClinicalTrials.gov Identifier: | NCT00842296 |
Other Study ID Numbers: |
CLF-05-03 |
First Posted: | February 12, 2009 Key Record Dates |
Results First Posted: | December 11, 2017 |
Last Update Posted: | March 12, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
GSV RadioFrequency |