MechanO-Chemical Ablation Versus CompreSSion

NCT04441957 | Unknown

• 1 other identifier: 20140456
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).

Conditions

Varicose Veins; Surgery

Keywords

VV; MOCA; GSV; Venous Ulcers

Outcome Measures

Primary Outcomes (5)

• Number of Participants with varicose Veins from absent (score 0) to severe (score 3).

  None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)

  6-12 months

• Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).

  None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)

  6-12 months

• Number of Participants with induration from absent (score 0) to severe (score 3).

  None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)

  6-12 months

• Number of Participants with active ulcers from absent (score 0) to severe (score 3).

  None (0), 1 (1), 2 (2), more than 2 (3)

  6-12 months

• Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).

  None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)

  6-12 months

Secondary Outcomes (1)

• Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1)

  3-24 months

Study Arms (2)

Group A, MOCA-group

Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression

Device: Endovenous Mechano- Chemical Ablation

Group B, Elastic Compression only group

Treatment: Elastic Compression only

Interventions

Endovenous Mechano- Chemical Ablation DEVICE

The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.

Also known as: MOCA

Group A, MOCA-group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with GSV incompetence and C6 were included in in the prospective consecutive case study if they satisfied the selection criteria.

You may qualify if:

• Patient age \> 18 years.
• Current leg ulceration of greater than 6 weeks.
• Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
• Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6.
• Able to give informed consent to participate in the study after reading the patient information documentation.
• Ankle Brachial Pressure Index (ABPI) ≥ 0.8.

You may not qualify if:

• Postoperative varicose veins disease recurrence.
• Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
• Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
• History of pulmonary embolism or stroke.
• Current anticoagulation therapy (within 7 days of enrollment).
• Pregnant or lactating women.

Sponsors & Collaborators

• Belarusian State Medical University: lead
• Medical University of Warsaw: collaborator

Study Sites (1)

Educational Institution "Belarusian State Medical University"

Minsk, Dzerzhinski Ave., 83,, 220116, Belarus

RECRUITING

Related Publications (5)

• Kanchanabat B, Stapanavatr W, Kanchanasuttiruk P. Total superficial vein reflux eradication in the treatment of venous ulcer. World J Surg. 2015 May;39(5):1301-5. doi: 10.1007/s00268-014-2935-y.

  PMID: 25680797 BACKGROUND

• Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.

  PMID: 15183623 BACKGROUND

• Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.

  PMID: 29688123 BACKGROUND

• Sullivan LP, Quach G, Chapman T. Retrograde mechanico-chemical endovenous ablation of infrageniculate great saphenous vein for persistent venous stasis ulcers. Phlebology. 2014 Dec;29(10):654-7. doi: 10.1177/0268355513501301. Epub 2013 Aug 22.

  PMID: 23969489 BACKGROUND

• Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012 Mar;27(2):67-72. doi: 10.1258/phleb.2011.010100. Epub 2011 Jul 29.

  PMID: 21803800 BACKGROUND

MeSH Terms

Conditions

Varicose Veins; Varicose Ulcer

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vladimir MD Khryshchanovich, Prof

  Educational Institution "Belarusian State Medical University"

  STUDY CHAIR

Central Study Contacts

Vladimir MD Khryshchanovich, Prof

CONTACT

+375296245578; vladimirkh77@mail.ru

Robert MD Proczka

CONTACT

+37548601332752; ramjup@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: January 1, 2018
• Primary Completion: June 15, 2020
• Study Completion: December 31, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12.2021
• Access Criteria: To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).

Locations

BE (1)