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ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
1.Primary Outcome
Title Percentage of Limbs Without Vein Occlusion
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
350 limbs were evaluated at the 12M timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
293 limbs were evaluated at the 3Y timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
275 limbs were evaluated at the 4Y timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
279 limbs were evaluated at the 5Y timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
363 limbs were evaluated at the 6M timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
350 limbs were evaluated at the 12M timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
329 limbs were evaluated at the 2Y timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
293 limbs were evaluated at the 3Y timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
275 limbs were evaluated at the 4Y timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
279 limbs were evaluated at the 5Y timepoint
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide Description Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide Description Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide Description Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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
Hide Description Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei
Hide 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%
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
Hide 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%)    
Hide 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)
Hide 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%)    
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
Layout table for Results Point of Contact information
Name/Title: Stephanie Brucato, Principal Clinical Research Specialist
Organization: Medtronic
Phone: 508-261-8000
EMail: stephanie.m.brucato@medtronic.com
Layout table for additonal information
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