- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835559
Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins (CASS)
Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jin Hyun Joh, MD, PhD
- Phone Number: +82-2-440-6261
- Email: vascularjoh@gmail.com
Study Locations
-
-
Non US/Canada
-
Seoul, Non US/Canada, Korea, Republic of, 05278
- Recruiting
- In-Mok Jung
-
Contact:
- Jin H Joh
- Email: vascularjoh@gmail.com
-
Seoul, Non US/Canada, Korea, Republic of, 05278
- Recruiting
- Jin Hyun Joh
-
Contact:
- Jin H Joh
- Email: vascularjoh@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cyanoacrylate closure
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.
|
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.
Other Names:
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.
Other Names:
|
Active Comparator: Surgical stripping
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Closure rate of the target vein/ Absence of refluxing vein
Time Frame: 3 months
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative pain with visual analog scale
Time Frame: 3 days
|
The subject will be asked to rate pain on a 0-10 numeric rating scale.
(minimum-0 (best), maximum-10 (worst))
|
3 days
|
Ecchymosis
Time Frame: 3 days
|
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)
|
3 days
|
Venous Clinical Severity Score
Time Frame: 1, 3, 6, 12 and 24 months after treatment
|
Severity score on a 0-30 numeric rating scale ((minimum-0 (best), maximum-30 (worst))
|
1, 3, 6, 12 and 24 months after treatment
|
Acceptability of Quality of life score
Time Frame: 1, 3, 6, 12 and 24 months after treatment
|
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). |
1, 3, 6, 12 and 24 months after treatment
|
Satisfaction of the patients: satisfaction rate
Time Frame: 1, 3, 6, 12 and 24 months after treatment
|
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.
|
1, 3, 6, 12 and 24 months after treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jin Hyun Joh, MD, PhD, Kyung Hee University Hospital at Gangdong, Seoul, Korea
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-03-030-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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