Trial Outcomes & Findings for VenaSeal Sapheon Closure System Pivotal Study (VeClose) (NCT NCT01807585)
NCT ID: NCT01807585
Last Updated: 2018-06-26
Results Overview
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
COMPLETED
NA
242 participants
3 months
2018-06-26
Participant Flow
The VeClose pivotal study was a prospective, multicenter, randomized, controlled study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either VenaSeal SCS or radiofrequency ablation (RFA) therapy. Patients were treated between March 2013 and September 2013. There were 10 sites with 242 subjects.
The VeClose study had two phases: a roll-in phase and a randomization phase. At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization) as "roll-in cases". Following completion of the roll-in phase, the site entered the randomized phase where subjects were assigned to either VenaSeal SCS or RFA cohort.
Participant milestones
| Measure |
Roll-In (VenaSeal SCS)
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
|
VenaSeal SCS (Randomized Phase)
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
RFA (Randomized Phase)
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
108
|
114
|
|
Overall Study
3 Mos
|
20
|
108
|
113
|
|
Overall Study
COMPLETED
|
19
|
104
|
108
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VenaSeal Sapheon Closure System Pivotal Study (VeClose)
Baseline characteristics by cohort
| Measure |
Roll-In (VenaSeal SCS)
n=20 Participants
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
|
VenaSeal SCS (Randomized Phase)
n=108 Participants
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
RFA (Randomized Phase)
n=114 Participants
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.1 years
n=5 Participants
|
49.0 years
n=7 Participants
|
50.5 years
n=5 Participants
|
50.1 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Primary effectiveness was analyzed on the randomized cohort only and used an Intent to Treat (ITT) population, consisting of all treated subjects. The difference in success rates was calculated after imputing missing values with various methods.
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Outcome measures
| Measure |
VenaSeal SCS (Randomized Phase)
n=108 Participants
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA
|
RFA (Randomized Phase)
n=114 Participants
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
RFA (Randomized Phase)
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
|---|---|---|---|
|
Number of Participants With Complete Closure of the Target Vein at 3 Months
|
107 Participants
|
109 Participants
|
—
|
SECONDARY outcome
Timeframe: During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.Population: Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.
After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.
Outcome measures
| Measure |
VenaSeal SCS (Randomized Phase)
n=18 Participants
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA
|
RFA (Randomized Phase)
n=106 Participants
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
RFA (Randomized Phase)
n=113 Participants
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
|---|---|---|---|
|
Intraoperative Pain
|
1.28 scores on a scale
Standard Deviation 1.53
|
2.16 scores on a scale
Standard Deviation 2.23
|
2.35 scores on a scale
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: First follow up visit at day 3Population: Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.
At the Day 3 visit, the investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome. The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site. The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria: 0 rating = no ecchymosis, 1. rating = less than 25% ecchymosis, 2. rating = 25-50% ecchymosis, 3. rating = 50-75% ecchymosis, 4. rating = 75-100% ecchymosis, 5. rating = extension of ecchymosis above or below the treated area.
Outcome measures
| Measure |
VenaSeal SCS (Randomized Phase)
n=20 Participants
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA
|
RFA (Randomized Phase)
n=108 Participants
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
RFA (Randomized Phase)
n=114 Participants
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
|---|---|---|---|
|
Ecchymosis at Day 3
None
|
15 Participants
|
73 Participants
|
55 Participants
|
|
Ecchymosis at Day 3
<25%
|
5 Participants
|
29 Participants
|
38 Participants
|
|
Ecchymosis at Day 3
25-50%
|
0 Participants
|
3 Participants
|
16 Participants
|
|
Ecchymosis at Day 3
50-75%
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Ecchymosis at Day 3
75-100%
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Roll-In (VenaSeal SCS)
VenaSeal SCS (Randomized Phase)
RFA (Randomized Phase)
Serious adverse events
| Measure |
Roll-In (VenaSeal SCS)
n=20 participants at risk
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
|
VenaSeal SCS (Randomized Phase)
n=108 participants at risk
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
RFA (Randomized Phase)
n=114 participants at risk
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
|---|---|---|---|
|
Gastrointestinal disorders
Ischemic Colitis
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/108 • 3 years
|
0.00%
0/114 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/20 • 3 years
|
0.00%
0/108 • 3 years
|
0.88%
1/114 • Number of events 1 • 3 years
|
|
Vascular disorders
Symptomatic orthostatic hypotension
|
0.00%
0/20 • 3 years
|
0.93%
1/108 • Number of events 1 • 3 years
|
0.00%
0/114 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/20 • 3 years
|
0.93%
1/108 • Number of events 1 • 3 years
|
0.00%
0/114 • 3 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • 3 years
|
0.00%
0/108 • 3 years
|
0.88%
1/114 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/20 • 3 years
|
0.93%
1/108 • Number of events 1 • 3 years
|
0.00%
0/114 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
0.00%
0/20 • 3 years
|
0.93%
1/108 • Number of events 1 • 3 years
|
0.00%
0/114 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Left hip bone pain
|
0.00%
0/20 • 3 years
|
0.00%
0/108 • 3 years
|
0.88%
1/114 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Left knee arthroplasty
|
0.00%
0/20 • 3 years
|
0.00%
0/108 • 3 years
|
0.88%
1/114 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver cancer
|
0.00%
0/20 • 3 years
|
0.93%
1/108 • Number of events 1 • 3 years
|
0.00%
0/114 • 3 years
|
|
Cardiac disorders
Non ST elevation MI
|
0.00%
0/20 • 3 years
|
0.00%
0/108 • 3 years
|
0.88%
1/114 • Number of events 1 • 3 years
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
0.00%
0/20 • 3 years
|
0.00%
0/108 • 3 years
|
0.88%
1/114 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right breast invasive lobular carcinoma
|
0.00%
0/20 • 3 years
|
0.93%
1/108 • Number of events 1 • 3 years
|
0.00%
0/114 • 3 years
|
|
Surgical and medical procedures
Right knee arthroplasty
|
0.00%
0/20 • 3 years
|
0.00%
0/108 • 3 years
|
0.88%
1/114 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/20 • 3 years
|
0.93%
1/108 • Number of events 1 • 3 years
|
0.00%
0/114 • 3 years
|
Other adverse events
| Measure |
Roll-In (VenaSeal SCS)
n=20 participants at risk
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization). These subjects underwent the same preoperative and postoperative assessments (with the same schedule) as patients who underwent randomization.
|
VenaSeal SCS (Randomized Phase)
n=108 participants at risk
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
RFA (Randomized Phase)
n=114 participants at risk
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Following completion of the Roll-in phase, subjects were then randomized at each site in a 1:1 fashion to either VenaSeal SCS or RFA.
|
|---|---|---|---|
|
Vascular disorders
Phlebitis in treatment zone
|
10.0%
2/20 • Number of events 2 • 3 years
|
11.1%
12/108 • Number of events 13 • 3 years
|
7.9%
9/114 • Number of events 9 • 3 years
|
|
Vascular disorders
Phlebitis not in treatment zone
|
0.00%
0/20 • 3 years
|
7.4%
8/108 • Number of events 8 • 3 years
|
5.3%
6/114 • Number of events 6 • 3 years
|
|
Vascular disorders
Superficial vein thrombophlebitis
|
15.0%
3/20 • Number of events 3 • 3 years
|
0.00%
0/108 • 3 years
|
0.00%
0/114 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Other
|
10.0%
2/20 • Number of events 3 • 3 years
|
7.4%
8/108 • Number of events 9 • 3 years
|
0.00%
0/114 • 3 years
|
Additional Information
Melissa Hasenbank, Clinical Research Director
Medtronic Endovascular
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place