A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
203
The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.
The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux.
ClinRe
Thornton, Colorado, United States
Pacific Vascular Institute
Kailua, Hawaii, United States
Eastlake Cardiovascular
Roseville, Michigan, United States
Englewood Hospital
Englewood, New Jersey, United States
Occlusion
Cumulative Incidence of Occlusion
Time frame: 1-Month
DVT & PE Serious Adverse Events
Cumulative Incidence of Device and Procedural Related Deep venous thrombosis \& Pulmonary Embolism Serious Adverse Events
Time frame: 1-Month
revised Venous Clinical Severity Score (rVCSS)
Distribution of rVCSS score
Time frame: Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20)
Distribution of CIVIQ-20 score
Time frame: Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits
Clinical Etiological Anatomical Pathophysiological (CEAP)
Distribution of CEAP clinical class
Time frame: Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
Visual Analog Scale for Pain (VAS)
Distribution of VAS Pain score
Time frame: Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits
Recanalization
Proportion of Recanalization of treated veins
Time frame: 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits
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Atrium Health
Charlotte, North Carolina, United States
Christus Health
Tyler, Texas, United States
ClinRe
Colonial Heights, Virginia, United States
Duration of Procedure
Mean Duration of Procedure
Time frame: Day 1 Index Procedure visit
Endovenous Heat Induced Thrombosis (2-4)
Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4
Time frame: 1-Month (+7 days) visit