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Vascular Clinical Trials

C-TRACT |  FMD Registry  |  PAUSE  |  PAUSE ER |  RIETE |  SYMPHONY-PE | 


C-TRACT: Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy

Aims: The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy 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).
Diagnosis: Illiac obstructive post thrombotic syndrome
Principal Investigator/s: Alfonso Tafur, MD
IRB Approval Number: EH19-245
Sponsor: Washington University School of Medicine
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org 
Open to Enrollment: Yes


FMD Registry: The U.S. Registry for Fibromuscular Dysplasia

Aims: The purpose of this registry is to gather real-world information and about Fibromuscular Dysplasia (FMD). By analyzing patterns and trends found within the registry, physicians may be able to learn more about this condition and ultimately improve the treatment of future FMD patients.
Diagnosis: Patients with established diagnosis of Fibromuscular Dysplasia
Principal Investigator/s: Kambiz Zorriasateyn, MD
IRB Approval Number: EH21-149
Sponsor: Cleveland Clinic
Contact: Interested patients may contact Lucas Wathen at 847.503.6366 or email lwathen@northshore.org 
Open to Enrollment: Yes


PAUSE Virtual: Perioperative Anticoagulant Use for Surgery Evaluation VIRTUAL VISIT

Aims: To demonstrate that virtual perioperative anticoagulant management in two cohorts of patients taking warfarin (Cohort 1) or a DOAC (Cohort 2) is safe for patient care if done with use of a user-friendly, point-of-care, clinical decision aid.
Diagnosis: Atrial Fibrillation, Atrial Flutter, Venous Thromboembolism
Principal Investigator/s: Alfonso Tafur, MD
IRB Approval Number: EH22-334
Sponsor: McMaster University
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org
Open to Enrollment: Yes


Perioperative Anticoagulant Use for Surgery Evaluation-in the Emergency Registry (PAUSE-ER) Study. Patients Receiving Warfarin or a Direct Oral Anticoagulant (DOAC – apixaban, dabigatran, edoxaban or rivaroxaban) and Require an Urgent/Emergency Surgery or Procedure: A Prospective Registry Study

Aims: The proposed pre- and post-procedure management protocol is standardized but adjusted, according to patients’ renal function and the surgery/procedure-related bleed risk, to optimize patient safety and does not include heparin bridging.
Diagnosis: No diagnoses require but has urgent procedure/surgery, currently taking NOAC drugs
Principal Investigator/s: Alfonso Tafur, MD
IRB Approval Number: EH20-083
Sponsor: Abiomed
Contact: Interested patients may contact Marisa Durante at 847.570.2125 or email mdurante@northshore.org 
Open to Enrollment: Yes


RIETE: Computerized Registry of Patients with Venous Thromboembolism

Aims: The RIETE Registry is a multidisciplinary project aimed at providing information on the Internet that helps physicians improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy or extreme body weight), with the purpose of decreasing mortality, frequency of thromboembolic recurrences, as well as bleeding complications and arterial events. RIETE also aims to create predictive scores that help physicians to better identify patients with high risk of developing some of these complications.
Diagnosis: Acute deep vein thrombosis (DVT), pulmonary embolism (PE) and/or superficial venous thrombosis (SVT).
Principal Investigator/s: Alfonso Tafur, MD
IRB Approval Number: EH11-337
Sponsor: Manuel Monreal, Foundation for the study of venous thromboembolism (VTE) diseases
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org
Open to Enrollment: Yes


SYMPHONY-PE: Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

Aims: SYMPHONY-PE is intended to assess the safety and efficacy of the Symphony Thrombectomy System to treat subjects with acute pulmonary embolism. This is a prospective, multi-center, open label, and single arm study of the Symphony Thrombectomy System in acute pulmonary embolism. The results will be used to support regulatory clearance of the Symphony PE with an indication for use in this specific patient population. Enrollment for the study will be completed in 12-15 months. For each subject, their participation in the study will be approximately 1 month with the following timepoints: screening, intervention, 48-hour, discharge and 30 days.
Diagnosis: Pulmonary Embolism
Principal Investigator/s: Arman Qamar, MD
IRB Approval Number: EH23-422
Sponsor: ImperativeCare, Inc.
Contact: Interested patients may contact Caitlin Nagy at 847.503.6449 or email cnagy@northshore.org
Open to Enrollment: Yes