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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
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

  1. 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.
  2. 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.

  1. Age less than 18 years
  2. Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
  3. Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
  4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
  5. Absence of PTS of at least moderate severity
  6. 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)
  7. 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
  8. Inability to tolerate endovascular procedure due to acute illness, or general health
  9. Severe allergy to iodinated contrast refractory to steroid premedication
  10. Known allergy to stent or catheter components
  11. Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.05, or platelet count < 75,000/ml
  12. Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)
  13. Disseminated intravascular coagulation or other major bleeding diathesis
  14. Pregnancy (positive pregnancy test)
  15. Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
  16. 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.

Sites / Locations

  • University of Alabama - Birmingham
  • UCLA
  • St. Joseph's Vascular InstituteRecruiting
  • UCSFRecruiting
  • Yale New Haven HospitalRecruiting
  • Christiana Care HospitalRecruiting
  • Piedmont Heart Institute
  • Rush Medical CenterRecruiting
  • University of ChicagoRecruiting
  • NorthShore University Health SystemRecruiting
  • Northwestern UniversityRecruiting
  • AMITA Health Adventist
  • Prairie Education and Research Cooperative
  • Central DuPage
  • Indiana UniversityRecruiting
  • University of Iowa
  • University of Maryland
  • Mayo ClinicRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Washington University School of MedicineRecruiting
  • St. Elizabeth's Hospital
  • New York University Medical Center
  • New York Presbyterian-Weill Cornell MedicineRecruiting
  • University of Vermont Health Network - CVPHRecruiting
  • Staten Island Hospital
  • Stony Brook Hospital
  • University of North CarolinaRecruiting
  • University Hospitals Cleveland Medical Center
  • Jobst Vascular InstituteRecruiting
  • University of Oklahoma
  • Oregon Health & Sciences University
  • University of Pennsylvania
  • Thomas Jefferson University HospitalRecruiting
  • Temple University
  • University of Pittsburg
  • Rhode Island Hospital
  • University of Texas Health Science Center at Houston
  • Intermountain Healthcare
  • Inova Alexandria Hospital
  • University of VirginiaRecruiting
  • Gundersen Health SystemRecruiting
  • Medical College of WisconsinRecruiting

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

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
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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
No
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
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
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
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.
Time Frame
over 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Email
Derflerm@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patty Nieters, RN, BSN
Phone
314-362-3371
Email
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
Email
alfonso.soriano@providence.org
First Name & Middle Initial & Last Name & Degree
Karla Garcia
Email
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
Email
khadija.siddiqua@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Maya Aslam
Email
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
Email
celan.watts@yale.edu
First Name & Middle Initial & Last Name & Degree
Dana Alameddine
Email
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
Email
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
Email
karl_villaneuva@rush.edu
First Name & Middle Initial & Last Name & Degree
Jessica Daniel
Email
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
Email
plofton@radiology.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Rosemary Uy-Palmer
Phone
773-702-6514
Email
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
Email
mdurante@northshore.org
First Name & Middle Initial & Last Name & Degree
Caitlin Nagy
Email
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
Email
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
Email
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
Email
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
Email
pmcelroy@umc.edu
First Name & Middle Initial & Last Name & Degree
David Gordy, PhD
Phone
601-984-2541
Email
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
Email
nietersp@wustl.edu
First Name & Middle Initial & Last Name & Degree
Mary Clare Derfler
Phone
314-747-2372
Email
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
Email
mailto:Egg4001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Irina Lipai
Email
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
Email
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
Email
rebekah_roten@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Wendy Basinger
Email
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
Email
krisztina.hanus@promedica.org
First Name & Middle Initial & Last Name & Degree
Kelly Hallett
Phone
419-291-8792
Email
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
Email
kristen.bradigan@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Philip Lee
Email
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
Email
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
Email
srmeyers@gundersenhealth.org
First Name & Middle Initial & Last Name & Degree
Christine Roraff
Email
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
Email
eweil@mcw.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Weseman
Email
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)

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