Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

NCT03835559 | Unknown

• 1 other identifier: 2018-03-030-001
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

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.

Conditions

Occlusions Vein; Chronic Venous Insufficiency

Keywords

varicose vein; stripping; endovenous; ablation; Occlusion; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (5)

• Perioperative pain with visual analog scale

  3 days

• Ecchymosis

  3 days

• Venous Clinical Severity Score

  1, 3, 6, 12 and 24 months after treatment

• Acceptability of Quality of life score

  1, 3, 6, 12 and 24 months after treatment

• Satisfaction of the patients: satisfaction rate

  1, 3, 6, 12 and 24 months after treatment

Study Arms (2)

Cyanoacrylate closure

ACTIVE COMPARATOR

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.

Procedure: Cyanoacrylate closure; Procedure: Surgical stripping

Surgical stripping

ACTIVE COMPARATOR

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.

Procedure: Cyanoacrylate closure; Procedure: Surgical stripping

Interventions

Cyanoacrylate closure PROCEDURE

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.

Also known as: Cyanoacrylate closure for incompetent Saphenous vein

Cyanoacrylate closure; Surgical stripping

Surgical stripping PROCEDURE

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.

Also known as: Surgical stripping for incompetent Saphenous vein

Cyanoacrylate closure; Surgical stripping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (2)

In-Mok Jung

Seoul, Non US/Canada, 05278, South Korea

RECRUITING

Jin Hyun Joh

Seoul, Non US/Canada, 05278, South Korea

RECRUITING

Related Publications (5)

• 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.

  PMID: 12756353 RESULT

• 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.

  PMID: 18692348 RESULT

• 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.

  PMID: 25650040 RESULT

• 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.

  PMID: 27638993 RESULT

• 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.

  PMID: 27052039 RESULT

MeSH Terms

Conditions

Varicose Veins; Bites and Stings

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Jin Hyun Joh, MD, PhD

  Kyung Hee University Hospital at Gangdong, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Hyun Joh, MD, PhD

CONTACT

+82-2-440-6261; vascularjoh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Multicenter, prospective randomized controlled trial

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 8, 2019
• Study Start: April 10, 2019
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2021
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

KR (2)