Trial Outcomes & Findings for ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study. (NCT NCT00509392)

NCT ID: NCT00509392

Last Updated: 2017-07-12

Results Overview

Pain 0-10 scale (10 most severe)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 69 participants
• Primary outcome timeframe: 48 Hour
• Results posted on: 2017-07-12

Participant Flow

Recruitment from March - December 2007. Medical offices/clinics and university hospital.

Unit of analysis: limbs

Participant milestones

Measure	Radiofrequency (RF) Ablation Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)	RF / EVLA Bilateral treatment where one limb is treated with RFA and the contralateral limb is treated with EVL
Overall Study STARTED	32 42	33 37	4 8
Overall Study COMPLETED	32 42	33 37	4 8
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.

Baseline characteristics by cohort

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)	Total n=87 limbs Total of all reporting groups
Age, Categorical <=18 years	0 limbs n=77 limbs	0 limbs n=148 limbs	0 limbs n=225 limbs
Age, Categorical Between 18 and 65 years	40 limbs n=77 limbs	30 limbs n=148 limbs	70 limbs n=225 limbs
Age, Categorical >=65 years	6 limbs n=77 limbs	11 limbs n=148 limbs	17 limbs n=225 limbs
Age, Continuous	51.6 Years STANDARD_DEVIATION 12.8 • n=5 Participants	52.4 Years STANDARD_DEVIATION 15.3 • n=7 Participants	52.37 Years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	38 limbs n=77 limbs	31 limbs n=148 limbs	69 limbs n=225 limbs
Sex: Female, Male Male	8 limbs n=77 limbs	10 limbs n=148 limbs	18 limbs n=225 limbs
Region of Enrollment United States	25 limbs n=77 limbs	23 limbs n=148 limbs	48 limbs n=225 limbs
Region of Enrollment Germany	21 limbs n=77 limbs	18 limbs n=148 limbs	39 limbs n=225 limbs
VCSS	4.7 Scores on a scale STANDARD_DEVIATION 3.1 • n=77 limbs	4.9 Scores on a scale STANDARD_DEVIATION 2.8 • n=148 limbs	4.8 Scores on a scale STANDARD_DEVIATION 3.0 • n=225 limbs
CEAP CEAP Class 2	43 limbs n=77 limbs	36 limbs n=148 limbs	79 limbs n=225 limbs
CEAP Not CEAP Class 2	3 limbs n=77 limbs	5 limbs n=148 limbs	8 limbs n=225 limbs
CIVIQ	40.6 Score on a questionnaire STANDARD_DEVIATION 17.2 • n=77 limbs	40 Score on a questionnaire STANDARD_DEVIATION 14.5 • n=148 limbs	40.3 Score on a questionnaire STANDARD_DEVIATION 15.9 • n=225 limbs

PRIMARY outcome

Timeframe: 48 Hour

Population: Data available at 48 hr follow-up visit

Pain 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Pain	0.7 units on a scale Standard Deviation 0.9	1.9 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 1 Week

Population: Data available at 1-week follow-up visit.

Pain 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=40 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=36 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Pain	0.2 units on a scale Standard Deviation 0.6	1.8 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 2 Weeks

Population: Data available at 2-week follow-up visit

Pain 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=43 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=39 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Pain	0.1 units on a scale Standard Deviation 0.4	1.2 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 1 Month

Population: Data available at 1 month follow-up visit

Pain 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Pain	0.2 units on a scale Standard Deviation 0.8	0.4 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: 48 Hour

Population: Data available at 48hr visit

Tenderness 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Tenderness	0.9 units on a scale Standard Deviation 1.3	2.0 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 1 Week

Population: Data available at 1-week follow-up visit

Tenderness 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=40 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=36 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Tenderness	0.5 units on a scale Standard Deviation 1.2	1.6 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 2 Weeks

Population: Data available at 2-week follow-up visit

Tenderness 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=43 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=39 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Tenderness	0.3 units on a scale Standard Deviation 0.7	1.2 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 1 Month

Population: Data available at 1 month follow-up visit

Tenderness 0-10 scale (10 most severe)

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Tenderness	0.3 units on a scale Standard Deviation 1.0	0.5 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: 48 Hours post treatment (no baseline)

Population: Data available at 48hrs follow-up visit

0-5 scale (5 most severe) 0: None

1. <25%

2. 25-50%

3. 50-75%

4. 75-100%

5. Above or below treated (tx) segment

Outcome measures

Measure	Radiofrequency (RF) Ablation n=45 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Ecchymosis 0	30 limbs	8 limbs
Ecchymosis 1	15 limbs	13 limbs
Ecchymosis 2	0 limbs	14 limbs
Ecchymosis 3	0 limbs	5 limbs
Ecchymosis 4	0 limbs	1 limbs
Ecchymosis 5	0 limbs	0 limbs

PRIMARY outcome

Timeframe: 1 Week post treatment (no baseline)

Population: Data available at 1-week follow-up visit

0-5 scale (5 most severe) 0: None

1. <25%

2. 25-50%

3. 50-75%

4. 75-100%

5. Above or below tx segment

Outcome measures

Measure	Radiofrequency (RF) Ablation n=40 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=35 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Ecchymosis 0	26 limbs	9 limbs
Ecchymosis 1	13 limbs	12 limbs
Ecchymosis 2	0 limbs	10 limbs
Ecchymosis 3	1 limbs	4 limbs
Ecchymosis 4	0 limbs	0 limbs
Ecchymosis 5	0 limbs	0 limbs

PRIMARY outcome

Timeframe: 2 Weeks post treatment (no baseline)

Population: Intent to treat/ SP: Data available at 2-week follow-up visit

0-5 scale (5 most severe) 0: None

1. <25%

2. 25-50%

3. 50-75%

4. 75-100%

5. Above or below tx segment

Outcome measures

Measure	Radiofrequency (RF) Ablation n=43 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=39 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Ecchymosis 0	35 limbs	13 limbs
Ecchymosis 1	7 limbs	18 limbs
Ecchymosis 2	1 limbs	6 limbs
Ecchymosis 3	0 limbs	2 limbs
Ecchymosis 4	0 limbs	0 limbs
Ecchymosis 5	0 limbs	0 limbs

PRIMARY outcome

Timeframe: 1 Month post treatment (no baseline)

Population: Data available at 1- month follow-up visit

0-5 scale (5 most severe) 0: None

1. <25%

2. 25-50%

3. 50-75%

4. 75-100%

5. Above or below tx segment

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=40 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Ecchymosis 0	45 limbs	31 limbs
Ecchymosis 1	1 limbs	9 limbs
Ecchymosis 2	0 limbs	0 limbs
Ecchymosis 3	0 limbs	0 limbs
Ecchymosis 4	0 limbs	0 limbs
Ecchymosis 5	0 limbs	0 limbs

PRIMARY outcome

Timeframe: 1 month

Population: Data up to one month follow up visit

Sequelae at any follow-up

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Complications Hyperpigmentation	1 limbs	0 limbs
Complications Phlebitis	0 limbs	8 limbs
Complications Paresthesia	2 limbs	3 limbs
Complications Erythema	0 limbs	6 limbs
Complications Infection	0 limbs	0 limbs
Complications Thrombus Extention (TE)/Deep Vein Thrombosis (DVT)	0 limbs	3 limbs

SECONDARY outcome

Timeframe: 48 Hours

Population: Data at 48 hours for follow up visit

Venous Clinical Severity Score (0-30 total overall score):

0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
VCSS	4.7 units on a scale Standard Deviation 1.6	6.2 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 1 Week

Population: Data at 1-week follow up visit

Venous Clinical Severity Score (0-30 total overall score):

0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Outcome measures

Measure	Radiofrequency (RF) Ablation n=40 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=35 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
VCSS	4.2 units on a scale Standard Deviation 1.5	5.9 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 2 Weeks

Population: Data at 2 week follow up visit

Venous Clinical Severity Score (0-30 total overall score):

0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Outcome measures

Measure	Radiofrequency (RF) Ablation n=43 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=39 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
VCSS	4.0 units on a scale Standard Deviation 1.8	5.3 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 1 Month

Population: Data at 1- month follow up visit

Venous Clinical Severity Score (0-30 total overall score):

0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Outcome measures

Measure	Radiofrequency (RF) Ablation n=46 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
VCSS	2.7 units on a scale Standard Deviation 2.2	3.2 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 48 Hours

Population: Data at 48 hrs follow up visit

Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).

Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.

Change from Baseline

Outcome measures

Measure	Radiofrequency (RF) Ablation n=44 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=40 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Change in CIVIQ QOL	-13.5 units on a scale Standard Deviation 14.6	-7.1 units on a scale Standard Deviation 19.0

SECONDARY outcome

Timeframe: 1 Week

Population: Data at one week follow up visit

Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).

Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.

Change from Baseline

Outcome measures

Measure	Radiofrequency (RF) Ablation n=33 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=35 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Change in CIVIQ QOL	-19.1 units on a scale Standard Deviation 13.9	-9.4 units on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: 2 Week

Population: Data at 2-week follow up visit

Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100).

Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.

Change from Baseline

Outcome measures

Measure	Radiofrequency (RF) Ablation n=40 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=36 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Change in CIVIQ QOL	-19.9 units on a scale Standard Deviation 14.7	-12.4 units on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: 1 Month

Population: Data at 1 month follow-up visit

Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).

Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.

Change from Baseline

Outcome measures

Measure	Radiofrequency (RF) Ablation n=43 limbs Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=39 limbs Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Change in CIVIQ QOL	-17.8 units on a scale Standard Deviation 15.4	-17.5 units on a scale Standard Deviation 15.2

Adverse Events

Radiofrequency (RF) Ablation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Endovenous Laser (EVL) Ablation

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Radiofrequency (RF) Ablation n=46 participants at risk Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 participants at risk Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Vascular disorders Thrombus extension (TE) into Common Femoral Vein (CFV)	0.00% 0/46 • 1 Month Number of subjects at risk = Number of subjects with adverse event information	2.4% 1/41 • Number of events 1 • 1 Month Number of subjects at risk = Number of subjects with adverse event information

Other adverse events

Measure	Radiofrequency (RF) Ablation n=46 participants at risk Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	Endovenous Laser (EVL) Ablation n=41 participants at risk Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
Skin and subcutaneous tissue disorders Hyperpigmentation	2.2% 1/46 • Number of events 1 • 1 Month Number of subjects at risk = Number of subjects with adverse event information	0.00% 0/41 • 1 Month Number of subjects at risk = Number of subjects with adverse event information
Vascular disorders Phlebitis	0.00% 0/46 • 1 Month Number of subjects at risk = Number of subjects with adverse event information	14.6% 6/41 • 1 Month Number of subjects at risk = Number of subjects with adverse event information
Nervous system disorders Paresthesia	2.2% 1/46 • Number of events 1 • 1 Month Number of subjects at risk = Number of subjects with adverse event information	4.9% 2/41 • 1 Month Number of subjects at risk = Number of subjects with adverse event information
Skin and subcutaneous tissue disorders Erythema	0.00% 0/46 • 1 Month Number of subjects at risk = Number of subjects with adverse event information	9.8% 4/41 • 1 Month Number of subjects at risk = Number of subjects with adverse event information

Additional Information

Eppie Chang, MS; Director Clinical Research

VNUS Medical Technologies / Covidien (sponsor)

Phone: 408-360-7200

Email: eppie.chang@covidien.com

Results disclosure agreements

• Principal investigator is a sponsor employee The data/info related to Study are legal property of VNUS \& can be used by PI for publication, communication or scientific presentation only after duly informing VNUS of proposed dissemination, providing to VNUS for review/comment a copy of said proposed publication, communication or scientific presentation \& allowing at least 30 days from the time of receipt by VNUS for VNUS to provide comment on said proposed publication, communication or scientific presentation prior to said dissemination.
• Publication restrictions are in place

Restriction type: OTHER