Presence Saint Joseph Medical Center

You don’t have to travel very far to get university level care. We conduct Clinical Research Trials right here at Presence Saint Joseph Medical Center.

Let our skilled team of clinical research coordinators, physicians, and specialists find the study that is right for you.

At PSJMC, safety is our highest priority.  We take extreme pride, care, and concern about how we conduct our clinical research trials.  Our trials are reviewed and approved by our professional Institutional Review Board (IRB) to ensure the safety of all participants. We are in full compliance with good clinical practices as defined under the U.S Food and Drug administration (FDA) regulations and the International Conference on Harmonisation 9 (ICH) guidelines.

The goal of our clinical trials is to improve the health of our participants, as we continue to strive for advancements in healthcare that will benefit future participants as well.

If you or someone you know are interested in any of our current trials and would like more information, please contact our Clinical Research Office at 815.773.7031 or 7657. 

   

Cardiovascular:

+ PLATINUM Diversity: Outcomes with the Promus PREMIER™ Stent in Women and Minorities

Principal Investigator: Chris Kolyvas, MD  

Sub-Investigators: Muawia Martini, MD; George Aziz, MD

Sponsor: Boston Scientific

Objective: To collect information on the procedure and clinical outcomes of the FDA approved Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIER stent) in understudied/underserved patient populations including women and minorities.

You may qualify for the PLATINUM study if you:

  • Have been or will be treated with at least one commercial Promus PREMIER stent.
  • Are female and/or a minority.

+ QP ExCELs – Extended CRT Evaluation with Quadripolar Left Ventricular Leads

Principal Investigator: Ahmad Karim, MD

Sub-Investigators: Sunil Shroff, MD and John Dongas, MD

Sponsor: BIOTRONIK, INC.

Objective: Pre-market: Confirm the safety and effectiveness of the BIOTRONIK Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 6 months post-implant. The evaluation of effectiveness will be based on LV pacing capture thresholds.   Post-approval: Confirm long-term safety of the BIOTRONIK Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 5 years post-implant.

You may be eligible for the QP ExCELs study if you:

·         Your doctor has determined that you need a cardiac resynchronization therapy defibrillator (CRT-D) system.

 

Cardiovascular/Pulmonology:

+ The Einstein Choice Study: Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the longterm prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism: The Einstein Choice Study

Principal Investigator: John Walsh, MD  

Sub-Investigator: Kristopher McDonough, MD and George Aziz, MD

Sponsor: Bayer HealthCare Pharmaceuticals 

Objective: The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to acetylsalicylic acid (ASA) 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism).

The secondary efficacy objective is to evaluate whether rivaroxaban 10 mg and rivaroxaban 20 mg are superior to ASA 100 mg in the prevention of the secondary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism, myocardial infarction, ischemic stroke, systemic non-central nervous system [CNS] embolism).

You may be eligible for the EINSTEIN trial if you:

  • Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week.

 

Liver Cancer:

+ TheraSphere HUD:Efficacy evaluation of TheraSphere in patients with inoperable liver cancer  

Authorized Physician: Joshua Tepper, MD; & Noah Schwind, MD

Objective: Patients with unresectable hepatocellular carcinoma (with or without portal vein thrombosis) or secondary liver cancer (i.e. patients have metastatic colorectal, breast, pancreatic and neuroendocrine cancer etc) will be eligible for this treatment protocol. As an HDE, TheraSphere can be used in the treatment of hypervascular liver lesions other than hepatocellular carcinoma as a matter of medical judgment. This is not a clinical investigation and requires neither an approved IDE nor compliance with CFR 50, CFR 56 or CFR 812. Off-indication use of TheraSphere is acceptable when, in the judgment of the physician:

1) there is no alternative therapeutic option for the patient and

2) no greater patient risk from use of the HDE product than that of the disease

You may be eligible for the TheraSphere if you:

  • Are >18 years of age
  • Have been diagnosed with hepatocellular carcinoma of the liver
  • Have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months

Are >4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy

 

Neurovascular:

+ Navigate ESUS: Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15mg once daily with aspirin 100mg once daily.  

Principal Investigator: Sherman Chen, MD

Sub-Investigators: Aamir Badruddin, MD; Dhruvil Pandya, MD; Amanda Benjamin, APN

Sponsor: Bayer HealthCare Pharmaceuticals

Objective: To find out whether an anti-clotting medication Rivaroxaban/Xarelto® leads to fewer blood clots in the brain (stroke) or in other blood vessels in the body when compared with aspirin in patients with a recent “embolic stroke of undetermined source” (ESUS).

The study is considered research because the study drug, Rivaroxaban/Xarelto® has not yet been approved by the relevant regulatory agency for treating this condition (Secondary prevention of stroke and systemic embolism in patients with a recent ESUS).

You may be eligible for the Navigate ESUS trial if you:

  • Have been recommended by your doctor
  • Are ≥ 18 years of age
  • Have had a recent “embolic stroke of undetermined source” (ESUS) in the last 7 days to 6 months.

 

+ POINT: Platelet-Oriented Inhibition in New TIA and minor ischemic stroke, a prospective, randomized, double-blind, multicenter clinical trial with the primary null hypothesis that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day

Principal Investigator: Aamir Badruddin, MD 

Sub-Investigators: Dhruvil Pandya, MD; Sherman Chen, MD  

Objective: To determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke.

You may be eligible for the POINT trial if you:

  • Are > 18 years of age
  • Experience a high risk TIA or minor stroke and are hospitalized < 12 hours from onset of symptoms
    Are able to tolerate aspirin at a dose of 50-325mg/day

 

STRATIS: Systematic Evaluation of Patients TReated with Neurothrombectomy Devices for AcuTe Ischemic Stroke (STRATIS) Registry 

Principal Investigator: Aamir Badruddin, MD

Sub-Investigators: Dhruvil Pandya, MD; Sherman Chen, MD

Sponsor: Covidien

Objective: To assess clinical outcomes associated with the use of Covidien market-released neurothrombectomy devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. 

You may be eligible for the STRATIS study if you:

  • Have been or will be treated with a Covidien market released neurothrombectomy device, for treatment of acute ischemic stroke.

 

+ TARGET®  Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360°, Target® Helical, and 2nd generation Target® Nano Coils

Principal Investigator: Aamir Badruddin, MD

Sub-Investigators: Dhruvil Pandya, MD; Sherman Chen, MD           

Objective: Target is a registry to collect prospective long-term safety and efficacy data on Stryker Target® 360°, Target® Helical and 2nd generation Target Nano coils used to treat people with an aneurysm.

You may be eligible for the Target study if you:

  • Are ≥ 18 years of age
  • Have a documented, previously untreated, saccular intracranial aneurysm suitable for embolization with coils

 

Type 1 Diabetes:

+ TrialNet: Natural History Study of the Development of Type 1 Diabetes: Screening

Principal Investigator: Tseghai Berhe, MD

Objective: An observational study to collect information which will enhance our understanding of the demographic,immunologic, and metabolic characteristics of individuals at risk for developing Type 1 Diabetes.

You may qualify for the TrialNet study if you:

  • Are 1-45 years of age and have an immediate family member with Type 1 Diabetes (such as a child, parent, or sibling)
  • Are 1-20 years old and have an extended family member with Type 1 Diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)

                 

Ophthalmology:

+ LADDER:  A Phase II Multicenter, Randomized Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients with Subforveal Neovascular Age-Related Macular Degeneration [LADDER]

Principal Investigator: John S. Pollack, MD 

Sub-Investigators: Joseph M. Civantos, MD

Sponsor: Genentech, Inc.

Objective: To evaluate the relative efficacy of 10-mg/mL, 40-mg/mL, and 100-mg/mL formulations of ranibizumab, delivered via the Implant, as measured by the time a patient first requires Implant refill according to protocol-defined refill criteria

You may be eligible for the LADDER study if you:

  • Are ≥ 50 years of age
  • Newly diagnosed with wet AMD within 6 months prior to screening visit
  • Patient must have received at least 2 prior anti-VEGF injections

 

Humanitarian Device (HUDS):

+ Neuroform ™ Microdelivery and Neuroform EZ Stent System

Authorized Physicians: Aamir Badruddin, MD; Dhruvil Pandya, MD;

Sherman Chen, MD; & Kaiz Asif, MD

 

Humanitarian Device. Authorized by Federal law for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2 mm and ≤ 4.5 mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck ≥ 4 mm or a dome-to-neck ratio <

 

+ CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System

Authorized Physicians: Aamir Badruddin, MD; Dhruvil Pandya, MD;

Sherman Chen, MD; & Kaiz Asif, MD

 

Humanitarian Device (USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤4 mm. Wide-neck is defined as having a neck width ≥4 mm or a dome-to-neck ratio <2.

 

+ Wingspan Stent System with Gateway™ PTA Balloon Catheter

–     HUD - approved by FDA in 2005 as a Humanitarian Device Exemption (HDE)

Authorized Physicians: Aamir Badruddin, MD; Dhruvil Pandya, MD;

Sherman Chen, MD; & Kaiz Asif, MD

 

Exempt from the efficacy data

Patients refractory to a comprehensive regimen of medical therapy with recurrent (2 or more) strokes or TIA due to atherosclerotic disease of intracranial vessels with 70-99% stenosis that are accessible to the system. The most recent stroke must have occurred more than 7 days prior to treatment with the Wingspan Stent System. Patients are eligible for treatment with the Wingspan Stent System if their Modified Rankin Score (mRS) is 3 or less at the time of treatment.

 

+ Graftmaster RX

Authorized Physicians: of Heartland and HeartCare Cardiologists

A Humanitarian Use Device (HUD) is a device intended to benefit patients treated or diagnosed with a disease or condition that affects less than 4,000 people in the U.S. per year

Graftmaster HUD indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter.

+ LVIS (Neuro-HUD) MicroVention Low-profile Intraluminal Support (LVIS and LVIS Jr.) Humanitarian Use Device (“LIVISHUD”) 

Authorized Physicians: Aamir Badruddin, MD; Dhruvil Pandya, MD;

Sherman Chen, MD; & Kaiz Asif, MD

Treatment of aneurysm device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year for the treatment of unruptured, wide-neck (neck ≥4 mm or dome to neck ratio

 

Pending Studies:

+DECAAF II:  Efficacy of DE-MRI-Guided Fibrosis Ablation vs. Conventional Catheter Ablation of Atrial Fibrillation [DECAAF II]

Principal Investigator: Ahmad Karim, MD

Sub-Investigators: Sunil Shroff, MD

Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF.

You may be eligible for the DECAAF II study if you:

  • You have been diagnosed with atrial fibrillation (AF) and are scheduled or will be scheduled to have an AF ablation procedure.

 

+PARFAIT: Protocol  CV006-004 Title: A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS-986141 For the Prevention of Recurrent Brain Infarction in Subjects receiving acetylsalicylic acid (ASA) following Acute Ischemic Stroke or Transient Ischemic Attack

Principal Investigator: Kaiz Asif, MD

Sub-Investigators: Aamir Badruddin, MD; Dhruvil Pandya, MD; & Sherman Chen, MD

Sponsor: Bristol-Meyers-Squibb

Objective: The purpose of this study is to determine if the study drug, BMS-986141, is safe and effective in preventings a future stroke when given daily to patients who have experienced acute ischemic stroke or transient ischemic attack (TIA) and are also taking acetylsalicylic acid (also known as aspirin or ASA).

You may be eligible for the PARFAIT study if you:

  • You were diagnosed with either an acute ischemic stroke or transient ischemic attack (TIA) within the last 48 hours.

 

+DELTA: Does Embolization with Larger coils lead to better Treatment of Aneurysms trial

Principal Investigator: Aamir Badruddin, MD

Sub-Investigators: Dhruvil Pandya, MD; & Sherman Chen, MD; Kaiz Asif, MD

Objective:  Aneurysms are commonly treated by coil embolization. Coils are metallic filaments introduced into the blood vessels of the brain with the help of catheters, to treat (that is block) the aneurysm; this is what is called “endovascular aneurysm embolization”.  The DELTA trial will test to see if embolization with larger coils leads to better treatment of aneurysms.

You may be eligible for the DELTA study if you:

  • You suffer from a brain aneurysm and you have already been scheduled to undergo endovascular treatment of your aneurysm.

If you or someone you know are interested in any of our current trials and would like more information, please contact our Clinical Research Office at 815.773.7031 or 7657