Clinical Trials and Research Program

Principal Investigator:
Mahmood Razavi, MD

Sub-Investigators:
Kurt Openshaw, MD
D. Preston Flanigan, MD
Donald J. Mahon, MD
Amer Jabara, MD
Crispin Mar, PA-C

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 stenoses in patients with systolic hypertension reduces the incidence of adverse cardiovascular and renal events compared with medical therapy alone. 

Principal Investigator:
Mahmood Razavi, MD

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

CLEVER: Claudication Exercise Vs. Endoluminal Revascularization

A prospective, multi-center, four-arm clinical trial with unbalanced randomization, testing 3 different hypotheses:

1. Aortoiliac revascularization with stent combined with optimal medical care improves maximum walking duration compared to optimal medical care (OMC) alone in pts with claudication and PAD who are amenable to peripheral stenting.
2. Regular supervised exercise (SE) + OMC improves max. walking duration compared to OMC in pts with claudication and PAD who are amenable to peripheral stenting.
3. Aortoiliac revascularization with stent combined with OMC improves max walking duration compared to SE + OMC in pts with claudication and PAD who are amenable to peripheral stenting.

Principal Investigator:
Mahmood Razavi, MD

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

CHOICE: Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence

A prospective, non-randomized, multi-center, descriptive, post-market study of two carotid artery stent systems and two embolic protection systems (RX Acculink/RX Accunet or Xact/Emboshield Barewire). The purpose of the study is to provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and to provide additional information that the devices can be used successfully by a wide range of physicians under commercial use conditions.

Principal Investigator:
Mahmood Razavi, MD

Sub-Investigators:
Howard Dorne, MD
Kurt Openshaw, MD
D. Preston Flanigan, MD
Crispin Mar, PA-C

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.

Principal Investigator:
Mahmood Razavi, MD

Sub-Investigators:
Kurt Openshaw, MD
Howard Dorne, MD
D. Preston Flanigan, MD
Crispin Mar, PA-C

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.

Sub-Investigators:
Kurt Openshaw, MD
Howard Dorne, MD
D. Preston Flanigan, MD
Crispin Mar, PA-C

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

This is an 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.

APPROVED VASCULAR HUMANITARIAN USE DEVICES (by FDA and IRB):

1. The Neuroform Microdelivery 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 greater than or equal to 2mm and greater than or equal to 4.5 mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck of greater than or equal to 4 mm or a dome-to-neck ratio of less than 2.  PI: Howard Dorne, MD
2. The 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.  PI: Howard Dorne, MD
3. The CORDIS 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 greater than or equal to 3mm and less than or equal to 4 mm. Wide-neck is defined as having a neck width greater than or equal to 4 mm or a dome-to-neck ratio less than 2.  PI: Howard Dorne. MD
4. Onyx Liquid Embolic System (Onyx HD-500) is indicated for treatment of intracranial, saccular, sidewall aneurysms  that present with a wide neck (greater than or equal to 4mm) or with a dome-to-neck ration less than 2 that are not amenable to treatment with surgical clipping.  PI: Howard Dorne, MD

Sub-Investigators:
Jairo Marin, MD
Lupe Ramos, NP
                                           

The primary objective is to evaluate the hypothesis that SCH 530348 added to standard of care will reduce the incidence of atherothrombotic ischemic events relative to standard of care alone, as measured by the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization.

Sub-Investigators:
Michael Chan, MD                                

The primary objective is to use the Triage touch to determine the optimal frequncy of home BNP testing and the changes in BNP concentrations to correlate with clinical HF decompensation and related adverse events in at-risk HF patients.

APPROVED CARDIAC HUMANITARIAN USE DEVICE (by FDA and IRB):

The 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.
PI: Dr. Donald Mahon