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

Primary Purpose

Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stents

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, superficial venous reflux, blood clot, post thrombotic syndrome, iliac vein obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must meet BOTH of these Criteria

Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > or = 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.
Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either:
1. Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
2. Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.

Exclusion Criteria: Subjects meeting any of these criteria will be excluded.

Age less than 18 years
Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
Absence of PTS of at least moderate severity
Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented)
Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg
Inability to tolerate endovascular procedure due to acute illness, or general health
Severe allergy to iodinated contrast refractory to steroid premedication
Known allergy to stent or catheter components
Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.05, or platelet count < 75,000/ml
Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)
Disseminated intravascular coagulation or other major bleeding diathesis
Pregnancy (positive pregnancy test)
Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
Inability to provide informed consent or to comply with study assessments

Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endovascular Therapy - Intervention

Non-Endovascular Therapy - Control

Arm Description

All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS. Subjects randomized to EVT will receive the following: imaging-guided iliac vein stent placement, and endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic. optimal PTS therapy: medical and compression, lifestyle interventions and venous ulcer care

All subjects will receive optimal PTS care as noted above.

Outcomes

Primary Outcome Measures

PTS Severity

374 patients with moderate to severe post thrombotic syndrome (PTS) and iliac vein obstruction will receive optimal PTS therapy. 50% of those patients will also receive endovenous therapy; modified antithrombotic therapy, including anti-platelet agent, iliac vein stenting, and endovenous ablation of refluxing saphenous veins if indicated. At 6 months post-randomization, venous clinical severity scores (VCSS) will be obtained and PTS severity will be evaluated.

Secondary Outcome Measures

Full Information

NCT ID

NCT03250247

First Posted

July 5, 2017

Last Updated

June 27, 2023

Sponsor

Washington University School of Medicine

Collaborators

Ontario Clinical Oncology Group (OCOG), Massachusetts General Hospital, St. Luke's Hospital, Kansas City, Missouri

1. Study Identification

Unique Protocol Identification Number

NCT03250247

Brief Title

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

Acronym

C-TRACT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 2, 2018 (Actual)

Primary Completion Date

February 29, 2024 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

Ontario Clinical Oncology Group (OCOG), Massachusetts General Hospital, St. Luke's Hospital, Kansas City, Missouri

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in patients with established disabling iliac-obstructive post thrombotic syndrome (DIO-PTS).

Detailed Description

The rationale for performing the C-TRACT Trial is based upon: the debilitating life impact of DIO-PTS upon patients, as cited in the U.S. Surgeon General's 2008 Call to Action on DVT (95); the inability of existing therapies to prevent or alleviate most cases of DIO-PTS; the role of iliac vein obstruction and saphenous reflux in causing the severe manifestations of DIO-PTS; the ability of stent placement and endovenous ablation to eliminate obstruction and reflux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies; the risks, costs, and uncertainties of this novel but invasive strategy; the lack of consensus on whether EVT should be used for DIO-PTS; the motivation of our established investigator team to answer this critical clinical question. We will determine if EVT should be routinely used to treat DIO-PTS. If so, this finding will fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and expensive procedures. 374 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT or No-EVT treatment groups. All participants will receive standard PTS therapy. Subjects will be enrolled over approximately 36 months in 20-40 U.S. Clinical Centers, and followed for 24 months. The study will take approximately 6 years to complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency, Venous Leg Ulcer, Venous Reflux, Post Thrombotic Syndrome

Keywords

deep vein thrombosis, superficial venous reflux, blood clot, post thrombotic syndrome, iliac vein obstruction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.

Masking

Outcomes Assessor

Masking Description

Blinded Clinical assessments for PTS will be obtained at baseline (pre-randomization) and at the 6- month follow-up visits. Examining clinicians will complete PTS training to ensure accuracy across all Clinical Centers. The examiners for PTS must be blinded to the subjects' treatment allocation. Subjects will be reminded not reveal to clinic staff which therapy they received (EVT or No-EVT). Subjects should be examined in the afternoon (the later the better) to allow the symptoms and signs of PTS to manifest. The assessment is performed as follows: The subject should be asked to rate the 5 symptoms on the Villalta PTS scale for each leg, record his/her ratings on the CRF. The subject's legs should be unclothed and he/she should be seated facing the blinded clinician (nurse or physician).The 5 signs of PTS and VCSS measures will be recorded by the blinded clinician. Leg ulcers (if present) will be assessed and measured.

Allocation

Randomized

Enrollment

374 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endovascular Therapy - Intervention

Arm Type

Experimental

Arm Description

Arm Title

Non-Endovascular Therapy - Control

Arm Type

No Intervention

Arm Description

All subjects will receive optimal PTS care as noted above.

Intervention Type

Device

Intervention Name(s)

Stents

Intervention Description

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.

Primary Outcome Measure Information:

Title

PTS Severity

Description

Time Frame

over 6 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must meet BOTH of these Criteria Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > or = 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator. Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either: Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV. Exclusion Criteria: Subjects meeting any of these criteria will be excluded. Age less than 18 years Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein Absence of PTS of at least moderate severity Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented) Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg Inability to tolerate endovascular procedure due to acute illness, or general health Severe allergy to iodinated contrast refractory to steroid premedication Known allergy to stent or catheter components Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.05, or platelet count < 75,000/ml Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min) Disseminated intravascular coagulation or other major bleeding diathesis Pregnancy (positive pregnancy test) Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS Inability to provide informed consent or to comply with study assessments Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Clare Derfler, RN MSN

Phone

314-973-0739

Derflerm@wustl.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Patty Nieters, RN, BSN

Phone

314-362-3371

nietersp@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suresh Vedantham, M.D.

Organizational Affiliation

Clinical Coordinating Center at Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama - Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Individual Site Status

Withdrawn

Facility Name

UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Withdrawn

Facility Name

St. Joseph's Vascular Institute

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alfonso Soriano

Phone

714-734-6220

alfonso.soriano@providence.org

First Name & Middle Initial & Last Name & Degree

Karla Garcia

karla.garcia@providence.org

First Name & Middle Initial & Last Name & Degree

Mahmood Razavi, MD

First Name & Middle Initial & Last Name & Degree

Kurt Openshaw, MD

First Name & Middle Initial & Last Name & Degree

Stacey Tien, PA-C

First Name & Middle Initial & Last Name & Degree

Tiffany Wu, MD

First Name & Middle Initial & Last Name & Degree

Bhavraj Khalsa, MD

Facility Name

UCSF

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khadija Siddiqua

Phone

415-476-4302

khadija.siddiqua@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Maya Aslam

maya.aslam@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Kanti Kolli, MD

First Name & Middle Initial & Last Name & Degree

Vishal Kumar, MD

First Name & Middle Initial & Last Name & Degree

Evan Lehrman, MD

First Name & Middle Initial & Last Name & Degree

Andrew Leavitt, MD

Facility Name

Yale New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caelan Watts

celan.watts@yale.edu

First Name & Middle Initial & Last Name & Degree

Dana Alameddine

dana.alameddine@yale.edu

First Name & Middle Initial & Last Name & Degree

Cassius Iyad Ochoa Chaar, MD

First Name & Middle Initial & Last Name & Degree

Alfred Lee, MD

First Name & Middle Initial & Last Name & Degree

Henry Hsia, MD

First Name & Middle Initial & Last Name & Degree

Naiem Nassiri, MD

First Name & Middle Initial & Last Name & Degree

Robert Attaran, MD

Facility Name

Christiana Care Hospital

City

Newark

State/Province

Delaware

ZIP/Postal Code

19718

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ann Marie LeNoir

Phone

302-733-4112

annlenoir@christianacare.org

First Name & Middle Initial & Last Name & Degree

Daniel Leung, MD

First Name & Middle Initial & Last Name & Degree

Michael Lankiewicz, MD

First Name & Middle Initial & Last Name & Degree

Assaf Graif, MD

First Name & Middle Initial & Last Name & Degree

Christopher Grilli, MD

First Name & Middle Initial & Last Name & Degree

Demetrios Agriantonis, MD

First Name & Middle Initial & Last Name & Degree

George Kimbiris, MD

Facility Name

Piedmont Heart Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Individual Site Status

Withdrawn

Facility Name

Rush Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karl Villaneuva

Phone

312-563-7305

karl_villaneuva@rush.edu

First Name & Middle Initial & Last Name & Degree

Jessica Daniel

Jessica_Daniel@rush.edu

First Name & Middle Initial & Last Name & Degree

Jordan Tasse, MD

First Name & Middle Initial & Last Name & Degree

Sreekumar Madassery, MD

First Name & Middle Initial & Last Name & Degree

Shivi Jain, MD

First Name & Middle Initial & Last Name & Degree

Bulent Arslan, MD

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pamel Lofton

Phone

773-702-2537

plofton@radiology.bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Rosemary Uy-Palmer

Phone

773-702-6514

RUy-Palmer@radiology.bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Osmanuddin Ahmed, MD

First Name & Middle Initial & Last Name & Degree

Jonathan Lorenz, MD

First Name & Middle Initial & Last Name & Degree

Jeffrey Leef, MD

First Name & Middle Initial & Last Name & Degree

Thuong Van Ha, MD

First Name & Middle Initial & Last Name & Degree

Rakesh Navuluri, MD

First Name & Middle Initial & Last Name & Degree

Kenneth Cohen, MD

Facility Name

NorthShore University Health System

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marisa Durante

Phone

847-570-2125

mdurante@northshore.org

First Name & Middle Initial & Last Name & Degree

Caitlin Nagy

CNagy@northshore.org

First Name & Middle Initial & Last Name & Degree

Alfonso Tafur, MD

First Name & Middle Initial & Last Name & Degree

Benjamin Lind, MD

Facility Name

Northwestern University

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristie Kennedy, MA

Phone

312-695-4023

kristie.kennedy@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Kush Desai, MD

First Name & Middle Initial & Last Name & Degree

Mark Eskandari, MD

First Name & Middle Initial & Last Name & Degree

Karlyn Martin, MD

First Name & Middle Initial & Last Name & Degree

Ramona Gupta, MD

First Name & Middle Initial & Last Name & Degree

Lindsey Kalhagen, MMS, PA-C

Facility Name

AMITA Health Adventist

City

LaGrange

State/Province

Illinois

ZIP/Postal Code

60439

Country

United States

Individual Site Status

Withdrawn

Facility Name

Prairie Education and Research Cooperative

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62769

Country

United States

Individual Site Status

Withdrawn

Facility Name

Central DuPage

City

Winfield

State/Province

Illinois

ZIP/Postal Code

60190

Country

United States

Individual Site Status

Withdrawn

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siji Mathachan

Phone

317-963-4786

simath@iu.edu

First Name & Middle Initial & Last Name & Degree

Sabah Butty, MD

First Name & Middle Initial & Last Name & Degree

Thomas Casciana, MD

First Name & Middle Initial & Last Name & Degree

Rakesh Mehta, MD

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Completed

Facility Name

University of Maryland

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Completed

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlene Blanchard

Phone

507-538-8152

blanchard.charlene@mayo.edu

First Name & Middle Initial & Last Name & Degree

Newton Neidert, MD

First Name & Middle Initial & Last Name & Degree

Damon Houghton, MD

First Name & Middle Initial & Last Name & Degree

Haraldur Bjarnason, MD

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pam McElroy

pmcelroy@umc.edu

First Name & Middle Initial & Last Name & Degree

David Gordy, PhD

Phone

601-984-2541

dgordy@umc.edu

First Name & Middle Initial & Last Name & Degree

Ajinkya Desai, MD

First Name & Middle Initial & Last Name & Degree

Laura Vick, MD

First Name & Middle Initial & Last Name & Degree

Rahat Noor, MD

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patty Nieters

Phone

314-362-3371

nietersp@wustl.edu

First Name & Middle Initial & Last Name & Degree

Mary Clare Derfler

Phone

314-747-2372

derflerm@wustl.edu

First Name & Middle Initial & Last Name & Degree

Suresh Vedantham, MD

First Name & Middle Initial & Last Name & Degree

Naganathan Mani, MD

First Name & Middle Initial & Last Name & Degree

Pavan Kavali, MD

First Name & Middle Initial & Last Name & Degree

Nassir Rostambeigi, MD

First Name & Middle Initial & Last Name & Degree

Alexander Ushinsky, MD

First Name & Middle Initial & Last Name & Degree

Elaine Majerus, MD

First Name & Middle Initial & Last Name & Degree

Morey Blinder, MD

First Name & Middle Initial & Last Name & Degree

Amy Zhou, MD

First Name & Middle Initial & Last Name & Degree

Kristen Sanfilippo, MD

First Name & Middle Initial & Last Name & Degree

Paula Vaughn, MD

Facility Name

St. Elizabeth's Hospital

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Individual Site Status

Completed

Facility Name

New York University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

New York Presbyterian-Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eli Gussen

Phone

646-962-4638

mailto:Egg4001@med.cornell.edu

First Name & Middle Initial & Last Name & Degree

Irina Lipai

irl2004@med.cornell.edu

First Name & Middle Initial & Last Name & Degree

Ronald Winokur, MD

First Name & Middle Initial & Last Name & Degree

Maria DeSancho, MD

First Name & Middle Initial & Last Name & Degree

Soo Rhee, MD

First Name & Middle Initial & Last Name & Degree

Christopher Harnain, MD

First Name & Middle Initial & Last Name & Degree

Hana Lim, MD

First Name & Middle Initial & Last Name & Degree

Kimberly Scherer, MD

First Name & Middle Initial & Last Name & Degree

Akhilesh Sista, MD

Facility Name

University of Vermont Health Network - CVPH

City

Plattsburgh

State/Province

New York

ZIP/Postal Code

12901

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marjori Lahar

Phone

518-562-7521

mlahar@cvph.org

First Name & Middle Initial & Last Name & Degree

Steven Deso, MD

First Name & Middle Initial & Last Name & Degree

Julio Lemos, MD

Facility Name

Staten Island Hospital

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Stony Brook Hospital

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebekah Roten

rebekah_roten@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Wendy Basinger

wendy_basinger@med.unc.edu

First Name & Middle Initial & Last Name & Degree

William Marston, MD

First Name & Middle Initial & Last Name & Degree

Raj Kasthuri, MD

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Jobst Vascular Institute

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kris Hanus

Phone

419-291-7182

krisztina.hanus@promedica.org

First Name & Middle Initial & Last Name & Degree

Kelly Hallett

Phone

419-291-8792

Kelly.hallett@promedica.org

First Name & Middle Initial & Last Name & Degree

John Fish, MD

First Name & Middle Initial & Last Name & Degree

Zakaria Assi, MD

First Name & Middle Initial & Last Name & Degree

Drew Oostra, MD

First Name & Middle Initial & Last Name & Degree

Jihad Abbas, MD

First Name & Middle Initial & Last Name & Degree

Babatunde Oriowo, MD

First Name & Middle Initial & Last Name & Degree

Andrew Seiwert, MD

First Name & Middle Initial & Last Name & Degree

Gregory Kasper, MD

First Name & Middle Initial & Last Name & Degree

Sophia Afridi, MD

Facility Name

University of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73014

Country

United States

Individual Site Status

Completed

Facility Name

Oregon Health & Sciences University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Completed

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Withdrawn

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristen Bradigan

kristen.bradigan@jefferson.edu

First Name & Middle Initial & Last Name & Degree

Philip Lee

philip.lee@downstate.edu

First Name & Middle Initial & Last Name & Degree

Taki Galamis, MD

First Name & Middle Initial & Last Name & Degree

Luis Eraso, MD

First Name & Middle Initial & Last Name & Degree

Robert Ford, MD

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of Pittsburg

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Individual Site Status

Withdrawn

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Intermountain Healthcare

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Individual Site Status

Withdrawn

Facility Name

Inova Alexandria Hospital

City

Alexandria

State/Province

Virginia

ZIP/Postal Code

22304

Country

United States

Individual Site Status

Withdrawn

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brigitte Kelly

Phone

434-297-7136

bjk3c@virginia.edu

First Name & Middle Initial & Last Name & Degree

Daniel Sheeran, MD

First Name & Middle Initial & Last Name & Degree

Luke Wilkins, MD

First Name & Middle Initial & Last Name & Degree

James Stone, MD

First Name & Middle Initial & Last Name & Degree

Adiyta Sharma, MD

Facility Name

Gundersen Health System

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Meyers

Phone

608-775-0238

srmeyers@gundersenhealth.org

First Name & Middle Initial & Last Name & Degree

Christine Roraff

cmroraff@gundersenhealth.org

First Name & Middle Initial & Last Name & Degree

Ezana Azene, MD

First Name & Middle Initial & Last Name & Degree

Todd Kowalski, MD

First Name & Middle Initial & Last Name & Degree

Clark Davis, MD

First Name & Middle Initial & Last Name & Degree

Jonanthan Zlabek, MD

First Name & Middle Initial & Last Name & Degree

Kurt Ziegelbein, MD

First Name & Middle Initial & Last Name & Degree

Irina Shaknovich, MD

First Name & Middle Initial & Last Name & Degree

Patrick Self, MD

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elizabeth Weil

Phone

414-805-2077

eweil@mcw.edu

First Name & Middle Initial & Last Name & Degree

Elizabeth Weseman

eweseman@mcw.edu

First Name & Middle Initial & Last Name & Degree

Eric Hohenwalter, MD.

First Name & Middle Initial & Last Name & Degree

James Gosset, MD

First Name & Middle Initial & Last Name & Degree

Kellie Brown, MD

First Name & Middle Initial & Last Name & Degree

Michael Malinowski, MD

First Name & Middle Initial & Last Name & Degree

Parag Patel, MD

First Name & Middle Initial & Last Name & Degree

Matthew Scheidt, MD

First Name & Middle Initial & Last Name & Degree

Brandon Key, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial