Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

NAActive, not recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

July 2, 2018

Primary Completion Date

January 30, 2026

Study Completion Date

April 27, 2026

Conditions
Deep Vein ThrombosisVenous StasisVenous InsufficiencyVenous Leg UlcerVenous RefluxPost Thrombotic Syndrome
Interventions
DEVICE

Stents

"US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram of CFV through infrarenal IVC.~Iliac vein should be pre-dilated to at least 12 mm. Bare, self-expanding stents made of elgiloy or nitinol legally marketed in the US for any indication and that are at least 12 mm in diameter should be used to recanalize the entire diseased segment of vein.~The use of devices \> 14 mm is highly recommended for the iliac vein and dilated to at least 14 mm, unless compelling patient factors dictates dilatation to a smaller diameter.~Balloon angioplasty of inflow veins.~After successful iliac vein recanalization, patients who continue to be symptomatic beyond 2 weeks follow-up and who have valvular reflux in GSV, accessory GSV, anterolateral thigh circumflex, and/or SSV should be offered endovenous ablation.~Any FDA-approved method may be used including radiofrequency or laser ablation, sclerotherapy or pharmacomechanical ablation."

Trial Locations (31)

10003

New York University Medical Center, New York

10065

New York Presbyterian-Weill Cornell Medicine, NewYork

10305

Staten Island Hospital, Staten Island

11794

Stony Brook Hospital, Stony Brook

12901

University of Vermont Health Network - CVPH, Plattsburgh

15213

University of Pittsburg, Pittsburgh

19107

Thomas Jefferson University Hospital, Philadelphia

19140

Temple University, Philadelphia

19718

Christiana Care Hospital, Newark

21201

University of Maryland, Baltimore

22908

University of Virginia, Charlottesville

27517

University of North Carolina, Chapel Hill

39216

University of Mississippi Medical Center, Jackson

43606

Jobst Vascular Institute, Toledo

44106

University Hospitals Cleveland Medical Center, Cleveland

46202

Indiana University, Indianapolis

52242

University of Iowa, Iowa City

53226

Medical College of Wisconsin, Milwaukee

54601

Gundersen Health System, La Crosse

60201

NorthShore University Health System, Evanston

60208

Northwestern University, Evanston

60612

Rush Medical Center, Chicago

60637

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

68510

St. Elizabeth's Hospital, Lincoln

73014

University of Oklahoma, Oklahoma City

77030

University of Texas Health Science Center at Houston, Houston

92868

St. Joseph's Vascular Institute, Orange

94143

UCSF, San Francisco

97239

Oregon Health & Sciences University, Portland

06510

Yale New Haven Hospital, New Haven

All Listed Sponsors
collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

Saint Luke's Mid America Heart Institute

UNKNOWN

lead

Washington University School of Medicine

OTHER