C-TRACT Study Site Questionnaire | New Image-Guided Treatments that Target Blood Clots

KEY PERSONNEL CONTACT INFORMATION

Name of Site

Address

City

State/Province

Zip/Postal

Country

Primary Contact Person

First and Last Name

Email Address

Phone Number

Site Principal Investigator (PI)

Email Address

Phone Number

PI Subspecialty

FACILITY INFORMATION

Please list the Primary Hospital at which you plan to enroll patients, as well as up to two major affiliate hospital that fall within your IRB’s jurisdiction.

Primary Hospital

Estimated yearly number of DVT Cases (irrespective of treatment type)

Estimated yearly number of patients with moderate-severe PTS (any treatment type)

Affiliate Hospital #1

Which category best describes the nature of your Primary Hospital?

University Hospital 

Community Hospital with Strong Academic Affiliation Private Hospital without Strong Academic Affiliation

OtherOther

Which of the following categories best describes the nature of Affiliate Hospital #1?

University Hospital 

Community Hospital with Strong Academic Affiliation

Private Hospital without Strong Academic Affiliation

Affiliate Hospital #2

Which of the following categories best describes the nature of Affiliate Hospital #2

University Hospital 

Community Hospital with Strong Academic Affiliation

Private Hospital without Strong Academic Affilation

Wound or Ulcer Care Clinic

Yearly number of patients seen

RESEARCH COORDINATOR INFORMATION

Research Coordinator

First and Last Name

Email Address

Phone Number

Number of Years Research Experience

ENDOVASCULAR THERAPY (EVT)

Primary Endovascular Co-Investigator (will oversee EVT)

First and Last Name

Email Address

Phone Number

Subspecialty

Number of years since completion of training

How many iliac vein stent procedures are performed in the group yearly?

How many are for treatment of chronic DVT with moderate-severe PTS?

What stent do you prefer?

MEDICAL AND COMPRESSIVE PTS THERAPY

Primary Medical Co-Investigator (will oversee standard PTS care)

First and Last Name

Email Address

Phone Number

Subspecialty

Number of years since completion of training

VENOUS ULCER CARE

Primary Ulcer Care Co-Investigator (will oversee venous ulcer care)

First and Last Name

Email Address

Phone Number

Subspecialty

Number of years since completion of training

How many venous ulcers has this investigator managed?

SITE-SPECIFIC ENROLLMENT AND DATA COLLECTION

Is your research team willing to engage in an active ongoing quality improvement program with study leadership to maximize the potential for enrollment?

Yes

Have you or your institution utilized electronic (e.g. EHR-based or electronic queries of other databases) methods of identifying patients for clinical research?

Yes

If yes, please specify

Vascular Ultrasound capabilities:

Is your ultrasound lab willing to identify patients for the C-TRACT study?

Yes

Is your ultrasound lab willing to complete web-based training to become qualified to submit ultrasound exams for study patients to a core lab?

Yes

Venogram Imaging capabilities:

Is your angiography lab willing and able to transfer pre- and post-procedure venograms to a core lab using a DICOM-compatible interface?

Yes

COMPETITIVE ENROLLMENT

Please name any studies at your site that expect to enroll patients with DVT or PTS from 2017-2020, and indicate how problems with competitive enrollment will be avoided.

STATEMENT OF CLINICAL EQUIPOISE

Does each co-investigator accept the premise that it is ethical and appropriate to randomize patients with moderate-severe PTS (including patients with venous ulcers less than 6 cm) to receive either EVT or no EVT in a trial (along with medical therapy, compression, and venous ulcer care as needed), and maintain them in their assigned treatment arm for 6-18 months (with rare exceptions)?

YES

Maybe

If the answer to this question is anything but an unequivocal YES, please explain

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