HEART DISEASE
----- Acute Coronary Syndrome (Coronary Artery Disease)
XIENCE V™ Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
Principal Investigator: Ramon Quesada, M.D.
A Clinical Evaluation of the 2.25 mm XIENCE V™ Everolimus Eluting Coronary Stent System
Principal Investigator: Ramon Quesada, M.D.
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Rajesh Dhairyawan, M.D.;
Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients (VIRGO)
This study is sponsored by the National Institute of Health: National Heart, Lung and Blood Institute.
Principal Investigator: Marcus St. John, MD
AngioSculpt Scoring Balloon Catheter Coronary Bifurcation Study
Principal Investigator: Ramon Quesada, M.D.
Switching from Arixtra (fondaparinux to Angiomax (bivalirudin) or unfractionated heparin in patients with acute coronary syndromes without ST-segment elevation undergoing percutaneous coronary intervention (PCI)( SWITCH III)
Principal Investigator: Ramon Quesada, M.D.
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Julius Gasso, M.D.; Rajesh Dhairyawan, M.D.
Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease(FREEDOM)This study is sponsored by the National Institute of Health: National Heart, Lung and Blood Institute.
Principal Investigator: Ramon Quesada, M.D.
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Julius Gasso, M.D.; Rajesh Dhairyawan, M.D.; Surgeon: Niberto Moreno, M.D.
----- Atrial Fibrillation
Continued Access to PROTECT AF Registry(CAP)
Principal Investigator: Ramon Quesada, M.D.
----- Structural Heart Disease
Registry: MitraClip vs. Surgery for Mitral Valve Regurgitation
EVERESTII: Real World Expanded Multi-Center Study of the Mitra Clip System (REALISM )
Principal Investigator: Ramon Quesada, M.D.
VASCULAR DISEASE
----- Abdominal Aortic Aneurysm
PRessure and Imaging—Using the CardioMEMS EndoSure™ Sensor for Long-term Follow-up after EVAR with Standard Surveillance (PRICELESS Prospective Registry)
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Peña, M.D.
-----Thoracic Aortic Aneurysm
A Phase II Clinical Study of the Safety and Efficacy of the Relay™Thoracic Stent-Graft in Patients with Thoracic Aortic Pathologies (Relay II)
Principal Investigator: Barry Katzen, M.D.
Co-investigators: James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Peña, M.D.
Aorfix™ AAA stent graft: Prospective aneurYsm Trial: High AnGle AORfix™ bifurcAted Stent graft (PYTHAGORAS)
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Peña, M.D.
----- Erectile Dysfunction
The Medtronic Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Peña, M.D. Y ekutiel Sandman, M.D.(Urologist)
----- Carotid Artery Disease
A Carotid Stenting Boston Scientific Surveillance Program( CABANA))
Principal Investigator, James Benenati M.D.
Co-Investigator: Barry Katzen, M.D.
Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients( ACT I)
Principal Investigator: Barry Katzen, M.D.
Surgeons: Athanassios Tsoukas, M.D.; OrlandoPuente, M.D.
Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy(SAPPHIRE WW)
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: James Benenati, M.D.; Italo Linfante, MD
Carotid Stenting For High Surgical Risk Patients; Evaluating Outcomes Through The CollectIon Of Clinical Evidence (“CHOICE”)
Principal Investigator, Barry Katzen, M.D.
Co-Investigator: James Benenati, M.D.
----- Peripheral Artery Disease
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 (DURABILITY II)
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Peña, M.D.
Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) This study is sponsored by the National Institute of Health: National Heart, Lung and Blood Institute.
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Peña, M.D.
Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (the ATTRACT Trial)
This study is sponsored by the National Institute of Health: National Heart, Lung and Blood Institute.
Principal Investigator: Shaun Samuels, M.D.
Co-Investigators: James Benenati, M.D.; Alex Powell, M.D.; M.D.; Constantino Peña, Barry Katzen, M.D.
Iliac artery treatmeNT with thE iNvatec Scuba cobalt chromium stEnt (INTENSE) Study
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Peña, M.D.
Neurovascular Disease
----- Brain Aneurysm
ENTERPRISE™ Vascular Reconstruction Device and Delivery System(HDE)
Principal Physician: Italo Linfante, M.D.
Onyx Liquid Embolic System Onyx(HDE)
Principal Physician: Italo Linfante, M.D.
Evaluation of Presidio and Cerecyte Coils in Large and Giant Aneurysms
Principal Physician: Italo Infante, MD
----- Atherosclerotic Disease
Vitesse Intracranial Stent Study for Ischemic Therapy( VISSIT)
Principal Investigator: Italo Linfante, M.D.
Wingspan™Stent System with Gateway PTA Balloon Catheter(HDE)
Principal Physician: Italo Linfante, M.D.
Radiation/Interventional Therapy/Imaging Studies
Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere® (YTTRIUM-90 GLASS MICROSPHERES)(HDE)In collaboration with Radiation Oncology(Andre Abitbol, M.D., Alan Lewin, M.D., Vivek Mishra, Ph.D.)
Principal Investigator: Shaun Samuels, M.D.
A Multicenter Phase 2 Study Comparing 99mTc‑EC‑DG SPECT/CT with 18F-FDG PET/CT in the Evaluation of Patients with Non-small Cell Lung Cancer (NSCLC)
In collaboration with Radiation Oncology(Andre Abitbol, M.D., Alan Lewin, M.D., Vivek Mishra, Ph.D.)
Principal Investigator: Hao V Vuong, M.D.
Evaluation of Dotarem®-Enhanced Magnetic Resonance Angiography (MRA) Compared to Time-of-Flight MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease (DGD-44-048)
Principal Investigator: Constantino Pena, M.D.
Co-Investigators Barry Katzen, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D. James Benenati, M.D.
Evaluation of Dotarem®-Enhanced Magnetic Resonance Angiography (MRA) Compared to Time-of-Flight MRA in the Diagnosis of Renal Arterial Disease (DGD-44-047)
Principal Investigator: Constantino Pena, M.D.
Co-Investigators Barry Katzen, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D. ; James Benenati, M.D