An additional element that separates Inovia Vein from other vein practices Oregon and nationally is that we are often on the cutting edge of the latest procedure options through our participation in collaborative national and international venous clinical trials. Given their controlled nature, clinical trials are some of the most accurate before and afters available and can be a resource for physicans and patients alike to evaluate the results of treatment options for common vein disorders.
Clinical trials are research studies that evaluate a new medical approaches, device, drug, or other treatment. As an Inovia Vein patient, you may have access to participate in the latest, advanced clinical trials in venous medicine. Pivotal randomized clinical trials are used to obtain evidence in a controlled fashion for the approval by the FDA in the United States. The data is usually presented for debate at the national scientific meetings and later published after extensive peer review in top medical journals.
At Inovia Vein, we have participated in some of the largest and most influential clinical trails in the vein world in recent years. We were and enrolling site for the VeClose trial, which was the pivotal study that led to the approval of Venaseal, and the Vanish Trial led to the approval of Varithena. Both of these options are now approved and are available as options for our patients at Inovia Vein.
What follows are a brief description of these trials, and links to the publications with the published results of the clinical trials comparing these forms of varicose vein treatment.
VeClose Trial for the Approval of VenaSeal
BackGround:
The VeClose Trial was the clinical trial that compared Venaseal (Cyanoacrylate, or CAC) with Closurefast (radio-frequency ablation, or RFA).
Purpose:
The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal CAC as being both 1) non-inferior to Closurefast RFA therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the reduction of intraprocedural and post procedural pain and symptoms as compared to treatment with Closurefast RFA. The study was designed to demonstrate safety of the VenaSeal CAC by follow-up visits that evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis and/or pulmonary embolus.
Clinical Trial Findings:
Both Venaseal and Closurefast RFA were effective in closure of the target GSV, resulting in similar and significant improvements in the patient’s quality of life through 24 months. These results suggest that CAC of the GSV is safe and durable out to 2 years.
Five-year clinical trial outcomes from the VeClose Extension Study were presented at the 2019 Charing Cross Symposium in London. The new data demonstrate durable and consistent long-term outcomes of the Venaseal for treating patients with chronic venous disease.
The now long term results of this trial suggest that both Closurefast RFA and Venaseal are durable, safe and effective options for patients with venous insufficiency. Thus we offer both and allow our patients to consider the options, and assist patients to choose what is best for them when a vein procedure is indicated.
ClinicalTrials.gov Identifiers (follow links for more information on clinical trial design):
VeClose Publications (Follow links to original publications):
Journal of Vascular Surgery (Venous and Lymphatic Disorders), May 2017: VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins.
Journal of Vascular Surgery (Venous and Lymphatic Disorders), September 2018: Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.
Journal of Vascular Surgery, April 2015: Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose).
The VANISH I Trial for the Approval of Varithena:
Background:
The VANISH I trial evaluated Polidocanol Endovenous Microfoam (also known commercially as Varithena)
Purpose:
Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam (also known PEM, or commercially as Varithena) Preparation Improves Symptoms and Appearance. This multicenter, parallel group study was designed to determine if a single administration of ≤15 mL of pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena) could alleviate symptoms and improve appearance of varicose veins in a typical population of patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the great saphenous vein (GSV) system.
Clinical Trail Findings:
This study demonstrated that a single administration of up to 15 mL of PEM (Varithena) is a safe, effective, and convenient treatment for the symptoms of superficial venous incompetence and the appearance of visible varicosities of the GSV system. Doses of 0.5%, 1%, and 2% PEM appear to have an acceptable risk-benefit ratio.
ClinicalTrials.gov Identifier (follow link for more information on clinical trial design):
VANISH Publications (Follow link to original publication):
European Journal of Vascular and Endovascular Surgery, December 2015: Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance.
Phlebology, October 2014: The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence.
Future Studies
Inovia Vein offers the full spectrum of advanced treatments for venous conditions, including varicose veins, spider veins, chronic venous insufficiency, deep vein thrombosis, venous ulcers and more. Our surgeons are nationally known for their expertise and have the skills and experience to treat even the most complex vein problems. We are often in discussion with collaborators nationally and internationally about participating in additional clinical trials. As new studies open for enrollment, we will make the option available to our patients at our clinics in NW Portland, Tigard, Happy Valley and Bend, Oregon.