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VenaSeal Sapheon Closure System Pivotal Study (VeClose) (VeClose)

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ClinicalTrials.gov Identifier: NCT01807585
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : June 26, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Sapheon, Inc.
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Great Saphenous Vein (GSV) With Venous Reflux Disease
Interventions Device: VenaSeal SCS
Device: ClosureFast Radiofrequency Ablation (RFA)
Device: Roll-in (VenaSeal SCS)
Enrollment 242
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started [1] 20 108 114
3 Mos [2] 20 108 113
Completed 19 104 108
Not Completed 1 4 6
[1]
Date of first Baseline Visit
[2]
Primary endpoint
Arm/Group Title Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase) Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 20 108 114 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 108 participants 114 participants 242 participants
53.1
(36 to 65)
49.0
(26 to 70)
50.5
(25 to 70)
50.1
(25 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 108 participants 114 participants 242 participants
Female
17
  85.0%
83
  76.9%
93
  81.6%
193
  79.8%
Male
3
  15.0%
25
  23.1%
21
  18.4%
49
  20.2%
1.Primary Outcome
Title Number of Participants With Complete Closure of the Target Vein at 3 Months
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 108 114
Measure Type: Count of Participants
Unit of Measure: Participants
107
  99.1%
109
  95.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VenaSeal SCS (Randomized Phase), RFA (Randomized Phase)
Comments Last Observation Carried Forward (LOCF)
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was determined by the application of a Z-test with a 10% non-inferiority margin as well as examination of confidence intervals.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One tailed Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-0.7 to 7.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Intraoperative Pain
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.
Arm/Group Title Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 18 106 113
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.28  (1.53) 2.16  (2.23) 2.35  (2.18)
3.Secondary Outcome
Title Ecchymosis at Day 3
Hide Description

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.
Time Frame First follow up visit at day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.
Arm/Group Title Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Hide Arm/Group Description:
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.
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
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 Number of Participants Analyzed 20 108 114
Measure Type: Count of Participants
Unit of Measure: Participants
None
15
  75.0%
73
  67.6%
55
  48.2%
<25%
5
  25.0%
29
  26.9%
38
  33.3%
25-50%
0
   0.0%
3
   2.8%
16
  14.0%
50-75%
0
   0.0%
2
   1.9%
4
   3.5%
75-100%
0
   0.0%
1
   0.9%
1
   0.9%
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      1/108 (0.93%)      0/114 (0.00%)    
Hide Serious Adverse Events
Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      5/108 (4.63%)      6/114 (5.26%)    
Cardiac disorders       
Non ST elevation MI  2  0/20 (0.00%)  0 0/108 (0.00%)  0 1/114 (0.88%)  1
Gastrointestinal disorders       
Ischemic Colitis  1  1/20 (5.00%)  1 0/108 (0.00%)  0 0/114 (0.00%)  0
Small Bowel Obstruction  2  0/20 (0.00%)  0 1/108 (0.93%)  1 0/114 (0.00%)  0
Infections and infestations       
Cellulitis  2  0/20 (0.00%)  0 0/108 (0.00%)  0 1/114 (0.88%)  1
Musculoskeletal and connective tissue disorders       
Cervical pain  2  0/20 (0.00%)  0 1/108 (0.93%)  1 0/114 (0.00%)  0
Left hip bone pain  2  0/20 (0.00%)  0 0/108 (0.00%)  0 1/114 (0.88%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer  2  0/20 (0.00%)  0 0/108 (0.00%)  0 1/114 (0.88%)  1
Thyroid Cancer  2  0/20 (0.00%)  0 1/108 (0.93%)  1 0/114 (0.00%)  0
Liver cancer  2  0/20 (0.00%)  0 1/108 (0.93%)  1 0/114 (0.00%)  0
Right breast invasive lobular carcinoma  2  0/20 (0.00%)  0 1/108 (0.93%)  1 0/114 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Preeclampsia  2  0/20 (0.00%)  0 0/108 (0.00%)  0 1/114 (0.88%)  1
Psychiatric disorders       
Suicide attempt  2  0/20 (0.00%)  0 1/108 (0.93%)  1 0/114 (0.00%)  0
Surgical and medical procedures       
Left knee arthroplasty  2  0/20 (0.00%)  0 0/108 (0.00%)  0 1/114 (0.88%)  1
Right knee arthroplasty  2  0/20 (0.00%)  0 0/108 (0.00%)  0 1/114 (0.88%)  1
Vascular disorders       
Symptomatic orthostatic hypotension  2  0/20 (0.00%)  0 1/108 (0.93%)  1 0/114 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, CP-11616-01, Rev A
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Roll-In (VenaSeal SCS) VenaSeal SCS (Randomized Phase) RFA (Randomized Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/20 (35.00%)      26/108 (24.07%)      15/114 (13.16%)    
Musculoskeletal and connective tissue disorders       
Other  1  2/20 (10.00%)  3 8/108 (7.41%)  9 0/114 (0.00%)  0
Vascular disorders       
Phlebitis in treatment zone  1  2/20 (10.00%)  2 12/108 (11.11%)  13 9/114 (7.89%)  9
Phlebitis not in treatment zone  1  0/20 (0.00%)  0 8/108 (7.41%)  8 6/114 (5.26%)  6
Superficial vein thrombophlebitis  1  3/20 (15.00%)  3 0/108 (0.00%)  0 0/114 (0.00%)  0
1
Term from vocabulary, CP-11616-01, Rev A
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Melissa Hasenbank, Clinical Research Director
Organization: Medtronic Endovascular
Phone: 707-525-0111
EMail: melissa.hasenbank@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01807585    
Other Study ID Numbers: CP-11101-01
First Submitted: March 5, 2013
First Posted: March 8, 2013
Results First Submitted: February 5, 2018
Results First Posted: June 26, 2018
Last Update Posted: June 26, 2018