Heart and Vascular Center

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

Investigators Research Studies

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Christopher Loh, MD
D. Preston Flanigan, MD
Stacey Tien, PA-C

Open to enrollment

BOLSTER: A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAMBalloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease.

The study is for patients 21 years of age and older who has iliac arterial disease with claudication or ischemic rest pain.

Sponsor: Bard Peripheral Vascular

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Christopher Loh, MD
D. Preston Flanigan, MD
Stacey Tien, PA-C

Open to enrollment

BEST-CLI: Randomized, Multi-Center, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia.

The study is for patients 35 years of age and older who has infrainguinal arterial disease with ischemic rest pain or non-healing wound.

Sponsor: NIH and Brigham and Women's Hospital

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Christopher Loh, MD
Stacey Tien, PA-C

Open to Enrollment

VIRTUS: Safety and Efficacy of the Veniti ViciVenous Stent System when Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous segment.

The study is for patients 18 years of age and older with chronic non-malignant obstruction of the common femoral vein, external iliac vein or common iliac vein.

Sponsor: Veniti Inc.

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Christopher Loh, MD

D. Preston Flanigan, MD

Open to Enrollment

DANCE:Delivery of Dexamethasone to the Adventitia to Enhance Clinical Efficacy after Femoropopliteal Revascularization.

Prospective, multi-center, single-arm trial to document the effects of adventitial delivery of dexamethasone after balloon angioplasty or atherectomy and provisional stenting of the popliteal and/or superficial femoral artery, and contiguous peripheral arteries.

Sponsor: Mercator MedSystems

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Christopher Loh, MD
D. Preston Flanigan, MD
Michael Chan, MD


Closed to Enrollment
Follow-up only

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 trial. The primary objective is to determine if the initial use of Pharmacomechanical Catheter-Directed Thrombolysis (PCDT) is symptomatic patients with acute proximal deep vein thrombosis (DVT) reduces the occurence of the Post-Thrombotic Syndrome over 24 months follow-up.

Sponsor: NIH and Washington University

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
D. Preston Flanigan, MD
JStacey Tien, PA-C


Closed to Enrollment
Follow-up only

LEVANT 2: A Prospective, Multi-Center, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries.

LEVANT 2 REGISTRY : A Prospective, Multi-Center, LEVANT 2 Continuation Registry of the Moxy Drug Coated Balloon for Treatment of Femoropopliteal Arteries.

This study is to assess the safety and efficacy of the Moxy Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

Sponsor: LUTONIX

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Lawrence Santora, MD
Jairo Marin, MD


Closed to Enrollment
Follow-up only

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 Ardian

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Joel Neutel, MD

Pending study

REDUCE-HTN:REINFORCE

Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of HTN.

Sponsor: Boston Scientific

Principal Investigator:
Brian Kolski, MD

Pending study

LRP: The Lipid-Rich Plaque Study

Sponsor: InfraReDx

HUMANITARIAN USE DEVICES:

  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: Christopher Loh, MD
    Co-Investigators: Mahmood Razavi, MD

  3. WINGSPAN Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with > 50% stenosis that are accessible to the system.
    Principal Investigator: Christopher Loh, MD
    Co-Investigators: Mahmood Razavi, MD

  4. CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is intended 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.
    Principal Investigator: Christopher Loh, MD
    Co-Investigators: Mahmood Razavi, MD

  5. JOSTENT GraftMaster Coronary Stent Graft is intended for 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.
    Principal Investigator: Donald Mahon, MD
    Co-Investigators: Jairo Marin, MD; Lawrence Santora, MD; George Wesley, MD; Michael Chan, MD

Updated March 6, 2015 by SC.
For a complete listing of all clinical trials open to patients at St. Joseph Hospital, please click here.