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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 Co-Is Study Title, Design & Purpose

Principal Investigator:
Mahmood Razavi, MD

Co-Investigators:
Kurt Openshaw, MD
Christopher Loh, 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 trial. 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:
Jairo Marin, MD

Co-Investigators:
Michael Chan, MD
Donald Mahon, MD
Lawrence Santora, MD
Tyson Cobb, 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 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

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, multicenter, 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:
D. Preston Flanigan, MD
Stacey Tien, PA-C


Active, Closed to Enrollment

LEVANT 2: AProspective, 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 Multicenter, 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:
Kurt Openshaw, MD
D. Preston Flanigan, MD


Active, Closed 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:
Lawrence Santora, MD
Jairo Marin, MD
Lisa Evans, NP
Lupe Ramos, NP


Active, Closed 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 Ardian

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: 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 July 30, 2014, by SC.
For a complete listing of all clinical trials open to patients at St. Joseph Hospital, please click here.