Trial Outcomes & Findings for ClosureFAST - Radiofrequency Great Saphenous Vein Treatment (NCT NCT00842296)

NCT ID: NCT00842296

Last Updated: 2018-03-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 326 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2018-03-12

Participant Flow

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

Unit of analysis: limbs

Participant milestones

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Overall Study STARTED	326 396
Overall Study COMPLETED	326 396
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

only 395 out of 396 limbs reported a Baseline CEAP score

Baseline characteristics by cohort

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=396 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter.
Age, Continuous	50.8 years STANDARD_DEVIATION 13.3 • n=326 Participants
Sex: Female, Male Female	239 Participants n=326 Participants
Sex: Female, Male Male	87 Participants n=326 Participants
Region of Enrollment United States	101 participants n=326 Participants
Region of Enrollment Europe	225 participants n=326 Participants
CEAP C0	1 limbs n=395 limbs • only 395 out of 396 limbs reported a Baseline CEAP score
CEAP C1	5 limbs n=395 limbs • only 395 out of 396 limbs reported a Baseline CEAP score
CEAP C2	213 limbs n=395 limbs • only 395 out of 396 limbs reported a Baseline CEAP score
CEAP C3	110 limbs n=395 limbs • only 395 out of 396 limbs reported a Baseline CEAP score
CEAP C4	60 limbs n=395 limbs • only 395 out of 396 limbs reported a Baseline CEAP score
CEAP C5	4 limbs n=395 limbs • only 395 out of 396 limbs reported a Baseline CEAP score
CEAP C6	2 limbs n=395 limbs • only 395 out of 396 limbs reported a Baseline CEAP score

PRIMARY outcome

Timeframe: 6 Months

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

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=363 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Vein Occlusion	97.6 percentage of limbs Standard Error 0.8

PRIMARY outcome

Timeframe: 12 months

Population: 350 limbs were evaluated at the 12M timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=350 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Vein Occlusion	96.6 percentage of limbs Standard Error 0.9

PRIMARY outcome

Timeframe: 2 years

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

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=329 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Vein Occlusion	94.3 percentage of limbs Standard Error 1.2

PRIMARY outcome

Timeframe: 3 years

Population: 293 limbs were evaluated at the 3Y timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=293 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Vein Occlusion	92.8 percentage of limbs Standard Error 1.4

PRIMARY outcome

Timeframe: 4 years

Population: 275 limbs were evaluated at the 4Y timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=275 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Vein Occlusion	91.1 Percentage of limbs Standard Error 1.5

PRIMARY outcome

Timeframe: 5 years

Population: 279 limbs were evaluated at the 5Y timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=221 Participants Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Vein Occlusion	90.0 Percentage of limbs Standard Error 1.7

PRIMARY outcome

Timeframe: 6 months

Population: 363 limbs were evaluated at the 6M timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=363 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Reflux in the Treated Vein Segment	99.5 Percentage of limbs Standard Error 0.4

PRIMARY outcome

Timeframe: 12 months

Population: 350 limbs were evaluated at the 12M timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=350 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Reflux in the Treated Vein Segment	98.9 Percentage of limbs Standard Error 0.5

PRIMARY outcome

Timeframe: 2 years

Population: 329 limbs were evaluated at the 2Y timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=329 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Reflux in the Treated Vein Segment	97.8 Percentage of limbs Standard Error 0.8

PRIMARY outcome

Timeframe: 3 years

Population: 293 limbs were evaluated at the 3Y timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=293 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Reflux in the Treated Vein Segment	95.7 Percentage of limbs Standard Error 1.1

PRIMARY outcome

Timeframe: 4 years

Population: 275 limbs were evaluated at the 4Y timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=275 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Reflux in the Treated Vein Segment	94.0 Percentage of limbs Standard Error 1.3

PRIMARY outcome

Timeframe: 5 years

Population: 279 limbs were evaluated at the 5Y timepoint

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=279 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Percentage of Limbs Without Reflux in the Treated Vein Segment	93.7 Percentage of limbs Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=395 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification C2	213 limbs
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification C3	110 limbs
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification C4	60 limbs
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification C5	4 limbs
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification C6	2 limbs
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification C0	1 limbs
CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification C1	5 limbs

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=395 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
CEAP Classification C0	55 limbs
CEAP Classification C1	180 limbs
CEAP Classification C2	92 limbs
CEAP Classification C3	27 limbs
CEAP Classification C4	36 limbs
CEAP Classification C5	3 limbs
CEAP Classification C6	2 limbs

SECONDARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=371 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
CEAP Classification C0	67 limbs
CEAP Classification C1	173 limbs
CEAP Classification C2	84 limbs
CEAP Classification C3	10 limbs
CEAP Classification C4	35 limbs
CEAP Classification C5	1 limbs
CEAP Classification C6	1 limbs

SECONDARY outcome

Timeframe: 12 months

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

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=350 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
CEAP Classification C0	62 limbs
CEAP Classification C1	194 limbs
CEAP Classification C2	61 limbs
CEAP Classification C3	6 limbs
CEAP Classification C4	24 limbs
CEAP Classification C5	2 limbs
CEAP Classification C6	1 limbs

SECONDARY outcome

Timeframe: 5 years

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

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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=279 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
CEAP Classification C6	0 limbs
CEAP Classification C0	22 limbs
CEAP Classification C1	116 limbs
CEAP Classification C2	101 limbs
CEAP Classification C3	26 limbs
CEAP Classification C4	12 limbs
CEAP Classification C5	2 limbs

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=396 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up Baseline	4.4 VCSS Score Standard Deviation 2.5
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 1 week	4.1 VCSS Score Standard Deviation 1.7
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 3 months	1.3 VCSS Score Standard Deviation 1.8
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 6 months	1.0 VCSS Score Standard Deviation 1.5
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 12 months	0.9 VCSS Score Standard Deviation 1.6
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 2 years	0.9 VCSS Score Standard Deviation 1.5
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 3 years	1.1 VCSS Score Standard Deviation 1.5
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 4 years	1.0 VCSS Score Standard Deviation 1.4
Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up 5 years	1.5 VCSS Score Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=395 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Visual Analog Pain Scale (VAS) 1 week	1.2 units on a scale (0-10) Standard Deviation 1.9
Visual Analog Pain Scale (VAS) 3 months	0.4 units on a scale (0-10) Standard Deviation 1.2
Visual Analog Pain Scale (VAS) 6 months	0.2 units on a scale (0-10) Standard Deviation 0.8
Visual Analog Pain Scale (VAS) 12 months	0.2 units on a scale (0-10) Standard Deviation 1.1
Visual Analog Pain Scale (VAS) 2 years	0.2 units on a scale (0-10) Standard Deviation 0.7
Visual Analog Pain Scale (VAS) 3 years	0.2 units on a scale (0-10) Standard Deviation 1.0
Visual Analog Pain Scale (VAS) 4 years	0.1 units on a scale (0-10) Standard Deviation 1.0
Visual Analog Pain Scale (VAS) 5 years	0.2 units on a scale (0-10) Standard Deviation 1.1

SECONDARY outcome

Timeframe: 1 Week

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=395 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Ecchymosis	23 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Erythema	5 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Hematoma	4 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Infection	0 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Pain	7 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Paresthesia	6 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Phlebitis	5 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Skin Pigmentation	0 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Thermal Skin Injury	0 limbs
Presence of Complications From Greater Saphenous Vein (GSV) Intervention Thrombus Extension / DVT	6 limbs

SECONDARY outcome

Timeframe: 3 Months

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=371 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Presence of Complications From GSV Intervention Ecchymosis	0 limbs
Presence of Complications From GSV Intervention Erythema	0 limbs
Presence of Complications From GSV Intervention Hematoma	1 limbs
Presence of Complications From GSV Intervention Infection	0 limbs
Presence of Complications From GSV Intervention Pain	0 limbs
Presence of Complications From GSV Intervention Paresthesia	9 limbs
Presence of Complications From GSV Intervention Phlebitis	1 limbs
Presence of Complications From GSV Intervention Skin Pigmentation	4 limbs
Presence of Complications From GSV Intervention Thermal Skin Injury	0 limbs
Presence of Complications From GSV Intervention Thrombus Extension / DVT	3 limbs

SECONDARY outcome

Timeframe: 12 months

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=350 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Presence of Complications From GSV Intervention Ecchymosis	0 limbs
Presence of Complications From GSV Intervention Erythema	0 limbs
Presence of Complications From GSV Intervention Hematoma	0 limbs
Presence of Complications From GSV Intervention Infection	0 limbs
Presence of Complications From GSV Intervention Pain	2 limbs
Presence of Complications From GSV Intervention Paresthesia	1 limbs
Presence of Complications From GSV Intervention Phlebitis	0 limbs
Presence of Complications From GSV Intervention Skin Pigmentation	3 limbs
Presence of Complications From GSV Intervention Thermal Skin Injury	0 limbs
Presence of Complications From GSV Intervention Thrombus Extension / DVT	1 limbs

SECONDARY outcome

Timeframe: 5 years

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

Outcome measures

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=279 limbs Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Presence of Complications From GSV Intervention Ecchymosis	0 limbs
Presence of Complications From GSV Intervention Erythema	0 limbs
Presence of Complications From GSV Intervention Hematoma	0 limbs
Presence of Complications From GSV Intervention Infection	0 limbs
Presence of Complications From GSV Intervention Pain	1 limbs
Presence of Complications From GSV Intervention Paresthesia	2 limbs
Presence of Complications From GSV Intervention Phlebitis	0 limbs
Presence of Complications From GSV Intervention Skin Pigmentation	1 limbs
Presence of Complications From GSV Intervention Thermal Skin Injury	0 limbs
Presence of Complications From GSV Intervention Thrombus Extension / DVT	0 limbs

Adverse Events

ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei

Serious events: 10 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei n=326 participants at risk Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
Gastrointestinal disorders GI Bleed	0.31% 1/326 • Number of events 1 • 5 years 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.
Vascular disorders Thrombus extensions	1.8% 6/326 • Number of events 6 • 5 years 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.
Vascular disorders Pulmonary Emboli (PE)	0.31% 1/326 • Number of events 1 • 5 years 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.
General disorders Death (Unknown Cause)	0.61% 2/326 • Number of events 2 • 5 years 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.

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Brucato, Principal Clinical Research Specialist

Medtronic

Phone: 508-261-8000

Email: stephanie.m.brucato@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60