NYP/C = NewYork-Presbyterian/Columbia (177 Fort Washington Avenue, New York, NY)
NYP/WC = NewYork-Presbyterian/Weill Cornell (525 East 68th Street, New York, NY)
Bi-campus = Both locations
| TRIAL/SPONSOR | OBJECTIVE | PATIENT STUDY POPULATION | P I | Campus |
| CAROTID DISEASE TRIALS | ||||
| ACT I/Abbott | To demonstrate equivalence of carotid artery stenting using the Xact RX stent w/ the Emboshield Cerebral Protection System Compared to CEA. | Asymptomatic subjects with >= 80% stenosis. | William Gray, MD Y. Pierre Gobin, MD |
NYP/C (Gray) NYP/WC |
| ARMOUR | To evaluate the safety and effectiveness of the Mo.Ma device for cerebral protection in the treatment of internal carotid artery (ICA) stenosis, which may or may not involve the bifurcation of the CCA, in subjects considered to be at high surgical risk for complications during carotid endarterectomy (CEA). | High Risk for CEA. ≥ 80% stenosis for asymptomatic subjects or ≥ 50% stenosis for symptomatic subjects. | Issam Moussa, MD | NYP/WC |
| Carotid DVA/New Health Sciences, Inc. | A prospective, multi-center clinical trial to establish dynamic vascular analysis (DVA) indices for patients with carotid artery disease undergoing stenting procedure. | Patients treated for carotid artery stenosis | William Gray, MD | NYP/C |
| CHOICE/Abbott | To provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions. As well as providing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients. | High Risk for CEA, Symptomatic >50% carotid stenosis, Asymptomatic >80% carotid stenosis, Patients treated with RX ACCULINK and RX ACCUNET or the XACT with the EMBOSHIELD for carotid artery stenosis | William Gray, MD | NYP/C |
| CREATE/ev3 | To confirm the safety and effectiveness of the PROTÉGÉ ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFXTM Embolic Protection Device when used in the treatment of common and/or internal carotid artery stenosis for subjects with a high risk for complications during endarterectomy. | High Risk for CEA, Symptomatic >50% carotid stenosis, Asymptomatic >80% carotid stenosis | John Karwowski, MD | Bi-campus |
| CREST/NIH | Comparison of Carotid Stenting vs CEA. | Patients at low risk for carotid surgery | William Gray, MD Y. Pierre Gobin, MD |
NYP/C (Gray) NYP/WC |
| EMPIRE | Study of GORE Neuro Protection System in carotid stenting | Patients at high risk for carotid endarterectomy | William Gray, MD | NYP/C |
| SAPPIRE/Cordis | The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW). | High Risk for CEA, Symptomatic >50% carotid stenosis, Asymptomatic >80% carotid stenosis | Angela Vouyouka, MD | Bi-campus |
| SMART/ Abbott | To determine if carotid stenting will increase quality of life and cognitive functioning in patients with severe carotid stenosis due to increase cerebral blood flow following the procedure. | Patients with > 70% carotid stenosis | Ken Perrine, MD | NYP/WC |
| SONOMA/Boston Scientific | To confirm the safety of the NexStent Carotid Stent System and theFilterWire EZ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that may occur with the use of this system. | High Risk for CEA, Symptomatic >50% carotid stenosis, Asymptomatic >80% carotid stenosis | James McKinsey, MD | Bi-campus |
| AORTIC ANEURYSM TRIALS | ||||
| AAA - IDE/Medtronic | To evaluate the safety and efficacy of Talent Endograft. | Abdominal aortic aneurysm not repairable with a market- approved endograft and not amenable to open repair | James McKinsey, MD | Bi-campus |
| PIVOTAL/Medtronic | To compare endovascular repair using the AneuRx Stent System versus ultrasound surveillance for management of small (4 - 5 cm) abdominal aortic aneurysms. | Candidates that are low-to-moderate risk except for age and hypertension that are controlled with up to four drugs per the SVS/ISCVS comorbidity scoring system | Nicholas Morrissey, MD | Bi-campus |
| PYTHAGORAS/Lombard | To demonstrate the safety and efficacy of the Lombard Medical bifurcated endovascular stent graft (Aorfix) in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with necks of up to 60 degrees. | AAA > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic, OR AAA growth of > 5 mm within the previous six months, and/or including extension into common iliac artery, and/or Iliac aneurysm > 3.5 cm in max diameter | James McKinsey, M | Bi-campus |
| TAA - IDE/Medtronic | To evaluate the safety and efficacy of Talent Endograft. | Thoracoabdominal aneurysm not repairable with a market- approved endograft and not amenable to open repair | James McKinsey, MD | Bi-campus |
| TX2 Expanded Access/ Cook | To evaluate the safety and effectiveness of the Zenith TX2 THORACIC TAA Endovascular Graft. | Descending thoracic aneurysm w/ diameter >= 5.0cm and >= 0.5cm per year, or with degenerative or atherosclerotic ulcers | James McKinsey, MD | Bi-campus |
| LOWER EXTREMITY ARTERIAL DISEASE TRIALS | ||||
| Zilver PTX/Cook | To compare the long-term safety and effectiveness of the Zilver PTX Drug-Eluting Vascular Stent to percutaneous transluminal angioplasty. | Patients with up to two documented stenotic or occluded atherosclerotic lesions of the above-the-knee femoropopliteal artery | Nicholas Morrissey, MD | Bi-campus |
| VENOUS STASIS ULCER TRIALS | ||||
| PFAB Leg Compressor/SUN Scientific | To evaluate a new technology, the PFAB and Leg Compressor, designed to heal venous stasis ulcers more effectively by applying a bandage and compression to the ulcer. | Patients diagnosed with venous stasis ulcer | Ross Lyon, MD | Bi-campus |
| ILIAC STENTING TRIALS | ||||
| Complete SE | Percutaneous interventional treatment of iliac artery lesions using the Medtronic Complete Self-Expanding Iliac Stent | Patients with obstructive iliac atherosclerosis resulting in symptoms of claudication | William Gray, MD | NYP/C |
Study Coordinators
NewYork-Presbyterian/Columbia (NYP/C)
Trials under Drs. James McKinsey or Nicholas Morrissey
Study Coordinator: Diana Catz - (212) 342-4102
Trials under Dr. William Gray
Study Coordinators:
Vanessa Laroche (CREST) - (212) 342-3488
Miriam Lucca-Susana (EMPIRE) - (212) 342-3682
Mariamne Orta (ACT I) - (212) 342-5139
Diana Wong (Complete SE) - (212) 342 4761
NewYork-Presbyterian/Weill Cornell (NYP/WC)
Trials under Drs. John Karwowski, Angela Vouyouka or Ross Lyon
Study Coordinator: Erin Magennis - (212) 746-5949
Trials under Drs. Y. Pierre Gobin or Ken Perrine
Study Coordinator: Kim Salvaggio - (212) 746-0389
Trials under Dr. Issam Moussa
Study Coordinator: Dolores Reynolds - (212) 746-4629

