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Clinical Trials and Research Program

St. Joseph Hospital's Heart and Vascular Center physicians participate in a number of leading-edge research and clinical trials to improve patient outcomes.

Clinical Research Coordinator:
Sandy Chung, RN, BSN, CRN,CCRC
(714) 744-8795, email Sandy.Chung@stjoe.org

Cardiac and Vascular Studies

PI and Sub-Is Study Title, Design & Purpose

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Howard Dorne, MD
D. Preston Flanigan, MD
Michael Chan, MD

Open to enrollment

ATTRACT: Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis

This is a NIH-funded, Phase III, multi-center, randomized, open-label, assessor-blind, parallel two-arm, controlled clinical trail. The primary objective is to determine if the initial use of Pharmacomechanical Catheter-Directed Thrombolysis (PCDT) in symptomatic patients with acute proximal deep vein thrombosis (DVT) reduces the occurrence of the Post-Thrombotic Syndrome over 24 months follow-up.

Sponsor: NIH and Washington University

Principal Investigator:
Brian Palafox, MD

Co-Investigators:
Richard Gates, MD
Lisa Evans, NP
Lupe Ramos, NP

Open to Enrollment

BCT 197: A Two-Part, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study of BCT 197 for the Prevention of Acute Kidney Injury (AKI) in Patients Undergoing Elective Cardiac Surgery with Cardiopulmonary Bypass (CPB)

This is a phase II, proof-of-concept (PoC) study with a primary goal to determine the efficacy and safety of BCT 197 for the prevention of AKI in the context of cardiac surgery. There are no available medical therapies to prevent or treat acute kidney injury. This study will use a prevention design and if successful, development would proceed for the indication prevention of AKI in the context of cardiac surgery.

Sponsor: Novartis

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Lawrence Santora, MD
Jairo Marin, MD
Lisa Evans, NP
Lupe Ramos, NP

Open to Enrollment

SYMPLICITY HTN-3: Renal Denervation in Patients with Uncontrolled Hypertension

This is an international, multi-center, prospective, single-blind, randomized and controlled study. Its objective is to demonstrate that catheter-based renal denervation is a safe and effective treatment for uncontrolled hypertension.

Sponsor: Medtronic

Principal Investigator:
Mahmood Razavi, MD

Sub-Investigators:
Howard Dorne, MD
Kurt Openshaw, MD
D. Preston Flanigan, MD


Open to Enrollment

SAPPHIRE WW: Stenting and Angioplasty With Protection In Patients At High-Risk For Endarterectomy

A prospective, multi-center, observational study. The primary objective of the study is to estimate 30-day major adverse events rate of stenting with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery. The devices to be utilized are the Cordis PRECISE Stent, ANGIOGARD XP/RX Emboli Capture Guidewire.

Sponsor: J&J Cordis

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Howard Dorne, MD
D. Preston Flanigan, MD
Timothy Harward, MD
Jeffrey Ballard, MD


Active. Closed to Enrollment

DURABILITY II: The US Study for Evaluating Endovascular Treatments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By Using the Protégé Everflex Nitinol Stent System II

A prospective, multi-center, non-randomized study. The objective of the study is to evaluate the safety and effectiveness of primary stenting using the Protégé Everflex Self-Expanding Stent System compared to PTA performance goals for the treatment of stenotic, restenotic (from PTA only) or occluded lesions (non-stented) of the native superficial femoral artery or the superficial femoral and proximal popliteal arteries.

Sponsor: Covidien/ev3

Principal Investigator:
Mahmood Razavi, MD

Sub-Investigators:
Kurt Openshaw, MD
D. Preston Flanigan, MD
Amer Jabara, MD
Donald Mahon, MD


Active. Closed to Enrollment

CORAL: Cardiovascular Outcomes in Renal Atherosclerotic Lesions randomized and multi-center two-group clinical trial to assess the best treatment for patients with high blood pressure and renal artery stenosis; stenting with anti-hypertensive medical therapy, compared to medical therapy alone

A prospective, NIH-funded, multi-center, unblinded, two-arm randomized trial. It is designed to test the hypothesis that medical therapy with stenting of significant renal artery stenosis in patients with systolic hypertension reduces the incidence of adverse cardiovascular and renal events compared with medical therapy alone.

Sponsor: NIH & University of Toledo

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Howard Dorne, MD


Active. Closed to Enrollment

RENOVA: A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft

A prospective, multi-center, randomized concurrently-controlled study of two approaches to the treatment of subjects with stenotic lesions at the venous anastomosis of synthetic arteriovenous (AV) grafts placed to facilitate vascular access for hemodialysis. The purpose of the study is to compare effectiveness data on subjects randomized to treatment with percutaneous transluminal angioplasty and the FLAIR Endovascular Stent Graft versus subjects randomized to treatment with PTA only.

Sponsor: BARD Peripheral Vascular

Principal Investigator:
Michael Chan, MD

Co-Investigators:
Donald Mahon, MD
Jairo Marin, MD
Tyson Cobb, MD
Lawrence Santora, MD

Active. Closed to Enrollment

CHAMPION PHOENIX: A clinical trial comparing cangrelor to clopidogrel standard of care therapy in subjects who require percutaneous coronary intervention.

The primary objective is to demonstrate that in patients requiring PCI, cangrelor provides superior efficacy to clopidogrel SOC, as measured by a composite of all cause mortality, MI, IDR and stent thrombosis.

Sponsor: The Medicines Co.

Principal Investigator:
Jairo Marin, MD

Co-Investigator:
Michael Chan, MD
Donald Mahon, MD
Lawrence Santora, MD
Tyson Cobb, MD
George Wesley, MD


Active. Closed to Enrollment

CYPRESS: A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different durations of Dual Antiplatelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER® Stent

During Phase I (non-randomized phase) of this study, the primary objective is to assess the rate of target lesion failure in all-corner and on-label subjects implanted with the CYPHER® stent in native coronary artery or coronary artery bypass graft lesions. During Phase II (randomized phase) of this study, the primary objective is to assess safety (major and minor bleeding), MACCE, and ST rates in all-corner subjects treated with dual antiplatelet therapy for 12 or 30 months following CYPHER® stent implantation.

Sponsor: J&J Cordis

APPROVED HUMANITARIAN USE DEVICES (by FDA and IRB):

  1. MELODY TPV with ENSEMBLE Transcatheter Valve Delivery System is intended for use as an adjunct to surgery in the management of adult and pediatric patients with right ventricular outflow tract (RVOT) conduit dysfunction.
    Principal Investigator: Farhouch Berdjis, MD
    Co-Investigator: Richard Gates, MD
  2. Neuroform EZ Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of > 2mm and < 4.5 mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck of > 4 mm or a dome-to-neck ratio of < 2.
    Principal Investigator: Howard Dorne, MD
    Co-Investigators: Mahmood Razavi, MD; Kurt Openshaw, MD
  3. Wingspan Stent System with Gateway PTA Balloon Catheter is indicted for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with greater than or equal to 50% stenosis that are accessible to the system.
    Principal Investigator: Howard Dorne, MD
    Co-Investigators: Mahmood Razavi, MD; Kurt Openshaw, MD; D.P. Flanigan, MD
  4. The CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is authorized by the 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 > 3mm and < 4 mm. Wide-neck is defined as having a neck width > 4 mm or a dome-to-neck ratio < 2.
    Principal Investigator: Howard Dorne. MD
    Co-Investigators: Mahmood Razavi, MD; Kurt Openshaw, MD
  5. Onyx Liquid Embolic System Onyx HD-500 is indicated for treatment of intracranial, saccular, sidewall aneurysms that present with a wide neck (≥ 4mm) or with a dome-to-neck ration <2 that are not amenable to treatment with surgical clipping.
    Principal Investigator: Howard Dorne, MD
  6. JOSTENT Graftmaster Coronary Stent Graft and Delivery System is approved for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.
    Principal Investigator: Donald Mahon, MD

Updated January 8, 2013, by GM. For a complete listing of all clinical trials open to patients at St. Joseph Hospital,
please click here.