ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

• ClinicalTrials.gov Identifier: NCT00842296
• Recruitment Status: Completed
• First Posted: February 12, 2009
• Results First Posted: December 11, 2017
• Last Update Posted: March 12, 2018
• Sponsor: Medtronic Endovascular
• Information provided by (Responsible Party): Medtronic Endovascular

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Venous Reflux
• Intervention: Device: RF ablation (ClosureFAST)
• Enrollment: 326

Participant Flow

Recruitment Details	Recruitment from April 24, 2006- September 5, 2006. Medical offices/clinics and university hospital.
Pre-assignment Details

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Period Title: Overall Study
	Number of participants	Number of units (limbs)
Started	326	396
Completed	326	396
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description		Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter.
Overall Number of Baseline Participants		326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs		396
Baseline Analysis Population Description		326 patients were enrolled and 396 limbs were treated and are analyzed. Only 395 limbs provided baseline CEAP data.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	326 participants
		50.8 (13.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	326 participants
	Female	239 73.3%
	Male	87 26.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	326 participants
United States		101
Europe		225
CEAP [1] [2]; Measure Type: Number; Unit of measure: Limbs	Number Analyzed	395 limbs
C0		1
C1		5
C2		213
C3		110
C4		60
C5		4
C6		2
		[1] Measure Description: CEAP (Clinical/Etiology/Anatomy/Pathophysiology) Clinical Score: C0: No visible/palpable sign C1: Reticular spider veins C2: Simple varicose veins C3: Ankle edema C4: Skin pigmentation C5: Healed venous ulcer C6: Open venous ulcer 395 out of 396 limbs reported a Baseline CEAP score.; [2] Measure Analysis Population Description: only 395 out of 396 limbs reported a Baseline CEAP score

Outcome Measures

1. Primary Outcome

Title	Percentage of Limbs Without Vein Occlusion
Description	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.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	293
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	363
Mean (Standard Error); Unit of Measure: percentage of limbs
	97.6 (0.8)

2. Primary Outcome

Title	Percentage of Limbs Without Vein Occlusion
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

350 limbs were evaluated at the 12M timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	280
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	350
Mean (Standard Error); Unit of Measure: percentage of limbs
	96.6 (0.9)

3. Primary Outcome

Title	Percentage of Limbs Without Vein Occlusion
Description	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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	263
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	329
Mean (Standard Error); Unit of Measure: percentage of limbs
	94.3 (1.2)

4. Primary Outcome

Title	Percentage of Limbs Without Vein Occlusion
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

293 limbs were evaluated at the 3Y timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	229
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	293
Mean (Standard Error); Unit of Measure: percentage of limbs
	92.8 (1.4)

5. Primary Outcome

Title	Percentage of Limbs Without Vein Occlusion
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

275 limbs were evaluated at the 4Y timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	210
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	275
Mean (Standard Error); Unit of Measure: Percentage of limbs
	91.1 (1.5)

6. Primary Outcome

Title	Percentage of Limbs Without Vein Occlusion
Description	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.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

279 limbs were evaluated at the 5Y timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	221
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	279
Mean (Standard Error); Unit of Measure: Percentage of limbs
	90.0 (1.7)

7. Primary Outcome

Title	Percentage of Limbs Without Reflux in the Treated Vein Segment
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

363 limbs were evaluated at the 6M timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	293
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	363
Mean (Standard Error); Unit of Measure: Percentage of limbs
	99.5 (0.4)

8. Primary Outcome

Title	Percentage of Limbs Without Reflux in the Treated Vein Segment
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

350 limbs were evaluated at the 12M timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	280
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	350
Mean (Standard Error); Unit of Measure: Percentage of limbs
	98.9 (0.5)

9. Primary Outcome

Title	Percentage of Limbs Without Reflux in the Treated Vein Segment
Description	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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

329 limbs were evaluated at the 2Y timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	263
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	329
Mean (Standard Error); Unit of Measure: Percentage of limbs
	97.8 (0.8)

10. Primary Outcome

Title	Percentage of Limbs Without Reflux in the Treated Vein Segment
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

293 limbs were evaluated at the 3Y timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	229
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	293
Mean (Standard Error); Unit of Measure: Percentage of limbs
	95.7 (1.1)

11. Primary Outcome

Title	Percentage of Limbs Without Reflux in the Treated Vein Segment
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

275 limbs were evaluated at the 4Y timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	210
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	275
Mean (Standard Error); Unit of Measure: Percentage of limbs
	94.0 (1.3)

12. Primary Outcome

Title	Percentage of Limbs Without Reflux in the Treated Vein Segment
Description	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.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

279 limbs were evaluated at the 5Y timepoint

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	221
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	279
Mean (Standard Error); Unit of Measure: Percentage of limbs
	93.7 (1.3)

13. Secondary Outcome

Title	CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	395
Count of Units; Unit of Measure: limbs
C0	1 0.3%
C1	5 1.3%
C2	213 53.9%
C3	110 27.8%
C4	60 15.2%
C5	4 1.0%
C6	2 0.5%

14. Secondary Outcome

Title	CEAP Classification
Description	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.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	325
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	395
Count of Units; Unit of Measure: limbs
C0	55 13.9%
C1	180 45.6%
C2	92 23.3%
C3	27 6.8%
C4	36 9.1%
C5	3 0.8%
C6	2 0.5%

15. Secondary Outcome

Title	CEAP Classification
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Only 302 subjects (371 limbs) completed the 3 Month follow-up visit to provide data to this outcome measure.

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	302
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	371
Count of Units; Unit of Measure: limbs
C0	67 18.1%
C1	173 46.6%
C2	84 22.6%
C3	10 2.7%
C4	35 9.4%
C5	1 0.3%
C6	1 0.3%

16. Secondary Outcome

Title	CEAP Classification
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Only 280 subjects (350 limbs) completed the 12 Month follow-up visit to provide data to this outcome measure.

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	280
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	350
Count of Units; Unit of Measure: limbs
C0	62 17.7%
C1	194 55.4%
C2	61 17.4%
C3	6 1.7%
C4	24 6.9%
C5	2 0.6%
C6	1 0.3%

17. Secondary Outcome

Title	CEAP Classification
Description	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.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Only 221 subjects (279 limbs) completed the 5 Year follow-up visit to provide data to this outcome measure.

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	221
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	279
Count of Units; Unit of Measure: limbs
C0	22 7.9%
C1	116 41.6%
C2	101 36.2%
C3	26 9.3%
C4	12 4.3%
C5	2 0.7%
C6	0 0.0%

18. Secondary Outcome

Title	Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up
Description	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.
Time Frame	Baseline thru 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	396
Mean (Standard Deviation); Unit of Measure: VCSS Score
Baseline	4.4 (2.5)
1 week	4.1 (1.7)
3 months	1.3 (1.8)
6 months	1.0 (1.5)
12 months	0.9 (1.6)
2 years	0.9 (1.5)
3 years	1.1 (1.5)
4 years	1.0 (1.4)
5 years	1.5 (1.8)

19. Secondary Outcome

Title	Visual Analog Pain Scale (VAS)
Description	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
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	395
Mean (Standard Deviation); Unit of Measure: units on a scale (0-10)
1 week	1.2 (1.9)
3 months	0.4 (1.2)
6 months	0.2 (0.8)
12 months	0.2 (1.1)
2 years	0.2 (0.7)
3 years	0.2 (1.0)
4 years	0.1 (1.0)
5 years	0.2 (1.1)

20. Secondary Outcome

Title	Presence of Complications From Greater Saphenous Vein (GSV) Intervention
Description	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	395
Count of Units; Unit of Measure: limbs
Ecchymosis	23 5.8%
Erythema	5 1.3%
Hematoma	4 1.0%
Infection	0 0.0%
Pain	7 1.8%
Paresthesia	6 1.5%
Phlebitis	5 1.3%
Skin Pigmentation	0 0.0%
Thermal Skin Injury	0 0.0%
Thrombus Extension / DVT	6 1.5%

21. Secondary Outcome

Title	Presence of Complications From GSV Intervention
Description	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	371
Count of Units; Unit of Measure: limbs
Ecchymosis	0 0.0%
Erythema	0 0.0%
Hematoma	1 0.3%
Infection	0 0.0%
Pain	0 0.0%
Paresthesia	9 2.4%
Phlebitis	1 0.3%
Skin Pigmentation	4 1.1%
Thermal Skin Injury	0 0.0%
Thrombus Extension / DVT	3 0.8%

22. Secondary Outcome

Title	Presence of Complications From GSV Intervention
Description	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	350
Count of Units; Unit of Measure: limbs
Ecchymosis	0 0.0%
Erythema	0 0.0%
Hematoma	0 0.0%
Infection	0 0.0%
Pain	2 0.6%
Paresthesia	1 0.3%
Phlebitis	0 0.0%
Skin Pigmentation	3 0.9%
Thermal Skin Injury	0 0.0%
Thrombus Extension / DVT	1 0.3%

23. Secondary Outcome

Title	Presence of Complications From GSV Intervention
Description	Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description:	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Number of Participants Analyzed	326
Overall Number of Units Analyzed; Type of Units Analyzed: Limbs	279
Count of Units; Unit of Measure: limbs
Ecchymosis	0 0.0%
Erythema	0 0.0%
Hematoma	0 0.0%
Infection	0 0.0%
Pain	1 0.4%
Paresthesia	2 0.7%
Phlebitis	0 0.0%
Skin Pigmentation	1 0.4%
Thermal Skin Injury	0 0.0%
Thrombus Extension / DVT	0 0.0%

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	SAEs were collected through study closure at 5 years. An SAE was defined as any AE that led to death, to a serious deterioration in the health of a subject that resulted in a life-threatening injury, a permanent impairment of a body structure/body function, hospitalization or prolongation of existing hospitalization, in a medical or surgical intervention to prevent permanent impairment of body structures or a body function; or led to fetal distress, fetal death, or a congenital birth defect.
Arm/Group Title	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Arm/Group Description	Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
All-Cause Mortality
	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
	Affected / at Risk (%)
Total	2/326 (0.61%)
Serious Adverse Events
	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
	Affected / at Risk (%)	# Events
Total	10/326 (3.07%)
Gastrointestinal disorders
GI Bleed † 1 [1]	1/326 (0.31%)	1
General disorders
Death (Unknown Cause) †	2/326 (0.61%)	2
Vascular disorders
Thrombus extensions † 2 [2]	6/326 (1.84%)	6
Pulmonary Emboli (PE) † 3 [3]	1/326 (0.31%)	1
1 Term from vocabulary, GI Bleed; 2 Term from vocabulary, Thrombus extension; 3 Term from vocabulary, Pulmonary Emboli; † Indicates events were collected by systematic assessment; [1] Unrelated event, Fatal GI Bleed; [2] Thrombus extensions into the Common Femoral vein (CFV); [3] Pulmonary Emboli (PE)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
	Affected / at Risk (%)	# Events
Total	0/326 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Stephanie Brucato, Principal Clinical Research Specialist
• Organization: Medtronic
• Phone: 508-261-8000
• EMail: stephanie.m.brucato@medtronic.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Proebstle TM, Möhler 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.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT00842296
• Other Study ID Numbers: CLF-05-03
• First Submitted: February 10, 2009
• First Posted: February 12, 2009
• Results First Submitted: June 26, 2017
• Results First Posted: December 11, 2017
• Last Update Posted: March 12, 2018