search
Back to results

Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins (CASS)

Primary Purpose

Occlusions Vein, Chronic Venous Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cyanoacrylate closure
Surgical stripping
Sponsored by
Kyung Hee University Hospital at Gangdong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Occlusions Vein focused on measuring varicose vein, stripping, endovenous, ablation, Occlusion, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18 and 80 years of age at the time of enrollment
  • Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position
  • Diameter of saphenous vein between 2mm to 20mm (with standing position)
  • One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
  • Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5

Exclusion Criteria:

  • Previous treatment in targeted vein segment
  • Tortuous vein in which the delivery catheter cannot be inserted
  • Aneurysm of target vein segment >20 mm
  • Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux
  • Known hypercoagulable disorder
  • Active malignancy
  • Regular use of systemic anticoagulation
  • Current use of systemic anticoagulant
  • Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis
  • Unable to comply with the schedule and protocol evaluations
  • Unable to ambulate
  • Currently pregnant or breast feeding
  • Known sensitivity to cyanoacrylate adhesives
  • Symptomatic peripheral arterial disease with ankle-brachial index <0.9
  • Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment
  • Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol

Sites / Locations

  • In-Mok JungRecruiting
  • Jin Hyun JohRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cyanoacrylate closure

Surgical stripping

Arm Description

After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure for treatment of incompetent Saphenous Veins is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.

For treatment of incompetent Saphenous Veins, surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries under all types of anesthesia (general, spinal, regional block, or local anesthesia). The saphenous vein is then removed using a stripper. Compression stocking is apply.

Outcomes

Primary Outcome Measures

Closure rate of the target vein/ Absence of refluxing vein
The primary endpoint of the study is to evaluate the complete closure of the target vein where complete closure is defined as Doppler ultrasound showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5cm after cyanoacrylate closure and absence of refluxing vein or residual vein after surgical stripping as read by a qualified site technologist or investigator.

Secondary Outcome Measures

Perioperative pain with visual analog scale
The subject will be asked to rate pain on a 0-10 numeric rating scale. (minimum-0 (best), maximum-10 (worst))
Ecchymosis
The investigator will score the subjects ipsilateral leg of the occurrence of ecchymosis along treated segment, rated on a 0- to 5-point graded scale (0, none; 1, involving <25% of the treatment area; 2, 25%-50%; 3, 50%-75%; 4, 75%-100%; 5, extension above or below the treatment segment)
Venous Clinical Severity Score
Severity score on a 0-30 numeric rating scale ((minimum-0 (best), maximum-30 (worst))
Acceptability of Quality of life score
The quality of life scores are measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) and EuroQOL five dimensions questionnaire (EQ-5D). The AVVQs are scored using a questionnaire. The total score for the 13 questions ranges from 0 to 100 points, with 0 points indicating the best possible quality of life. The EuroQOL is an instrument which evaluates the generic quality of life. The EuroQOL descriptive system is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Satisfaction of the patients: satisfaction rate
The subject will be asked to the satisfaction rate by five response categories (strongly agree, agree, uncertain, disagree, strongly disagree) after asking as following: I'm very satisfied with the medical care I receive.

Full Information

First Posted
February 1, 2019
Last Updated
April 13, 2019
Sponsor
Kyung Hee University Hospital at Gangdong
search

1. Study Identification

Unique Protocol Identification Number
NCT03835559
Brief Title
Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins
Acronym
CASS
Official Title
Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.
Detailed Description
Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occlusions Vein, Chronic Venous Insufficiency
Keywords
varicose vein, stripping, endovenous, ablation, Occlusion, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyanoacrylate closure
Arm Type
Active Comparator
Arm Description
After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure for treatment of incompetent Saphenous Veins is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
Arm Title
Surgical stripping
Arm Type
Active Comparator
Arm Description
For treatment of incompetent Saphenous Veins, surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries under all types of anesthesia (general, spinal, regional block, or local anesthesia). The saphenous vein is then removed using a stripper. Compression stocking is apply.
Intervention Type
Procedure
Intervention Name(s)
Cyanoacrylate closure
Other Intervention Name(s)
Cyanoacrylate closure for incompetent Saphenous vein
Intervention Description
After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
Intervention Type
Procedure
Intervention Name(s)
Surgical stripping
Other Intervention Name(s)
Surgical stripping for incompetent Saphenous vein
Intervention Description
All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.
Primary Outcome Measure Information:
Title
Closure rate of the target vein/ Absence of refluxing vein
Description
The primary endpoint of the study is to evaluate the complete closure of the target vein where complete closure is defined as Doppler ultrasound showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5cm after cyanoacrylate closure and absence of refluxing vein or residual vein after surgical stripping as read by a qualified site technologist or investigator.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Perioperative pain with visual analog scale
Description
The subject will be asked to rate pain on a 0-10 numeric rating scale. (minimum-0 (best), maximum-10 (worst))
Time Frame
3 days
Title
Ecchymosis
Description
The investigator will score the subjects ipsilateral leg of the occurrence of ecchymosis along treated segment, rated on a 0- to 5-point graded scale (0, none; 1, involving <25% of the treatment area; 2, 25%-50%; 3, 50%-75%; 4, 75%-100%; 5, extension above or below the treatment segment)
Time Frame
3 days
Title
Venous Clinical Severity Score
Description
Severity score on a 0-30 numeric rating scale ((minimum-0 (best), maximum-30 (worst))
Time Frame
1, 3, 6, 12 and 24 months after treatment
Title
Acceptability of Quality of life score
Description
The quality of life scores are measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) and EuroQOL five dimensions questionnaire (EQ-5D). The AVVQs are scored using a questionnaire. The total score for the 13 questions ranges from 0 to 100 points, with 0 points indicating the best possible quality of life. The EuroQOL is an instrument which evaluates the generic quality of life. The EuroQOL descriptive system is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time Frame
1, 3, 6, 12 and 24 months after treatment
Title
Satisfaction of the patients: satisfaction rate
Description
The subject will be asked to the satisfaction rate by five response categories (strongly agree, agree, uncertain, disagree, strongly disagree) after asking as following: I'm very satisfied with the medical care I receive.
Time Frame
1, 3, 6, 12 and 24 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 years of age at the time of enrollment Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position Diameter of saphenous vein between 2mm to 20mm (with standing position) One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5 Exclusion Criteria: Previous treatment in targeted vein segment Tortuous vein in which the delivery catheter cannot be inserted Aneurysm of target vein segment >20 mm Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux Known hypercoagulable disorder Active malignancy Regular use of systemic anticoagulation Current use of systemic anticoagulant Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis Unable to comply with the schedule and protocol evaluations Unable to ambulate Currently pregnant or breast feeding Known sensitivity to cyanoacrylate adhesives Symptomatic peripheral arterial disease with ankle-brachial index <0.9 Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Hyun Joh, MD, PhD
Phone
+82-2-440-6261
Email
vascularjoh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Hyun Joh, MD, PhD
Organizational Affiliation
Kyung Hee University Hospital at Gangdong, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
In-Mok Jung
City
Seoul
State/Province
Non US/Canada
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin H Joh
Email
vascularjoh@gmail.com
Facility Name
Jin Hyun Joh
City
Seoul
State/Province
Non US/Canada
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin H Joh
Email
vascularjoh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study protocol
Citations:
PubMed Identifier
12756353
Citation
Kaplan RM, Criqui MH, Denenberg JO, Bergan J, Fronek A. Quality of life in patients with chronic venous disease: San Diego population study. J Vasc Surg. 2003 May;37(5):1047-53. doi: 10.1067/mva.2003.168.
Results Reference
result
PubMed Identifier
18692348
Citation
van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
Results Reference
result
PubMed Identifier
25650040
Citation
Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
Results Reference
result
PubMed Identifier
27638993
Citation
Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.
Results Reference
result
PubMed Identifier
27052039
Citation
Chan YC, Law Y, Cheung GC, Ting AC, Cheng SW. Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome. Phlebology. 2017 Mar;32(2):99-106. doi: 10.1177/0268355516638200. Epub 2016 Jul 9.
Results Reference
result

Learn more about this trial

Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

We'll reach out to this number within 24 hrs