Vascular Clinical Trials

Vascular

New York-Presbyterian Hospital's vascular surgeons are conducting multiple clinical trials on emerging treatments for vascular disease. Surgeons at NewYork-Presbyterian also hold academic titles at either of the Hospital's affiliate medical schools: Columbia University College of Physicians and Surgeons and Weill Cornell Medical College. Although Hospital facilities are generally used for the trials, they are actually conducted under the supervision of the physician's medical college. Below is a listing of current clinical trials for vascular disease.

Current Clinical Trials for Vascular Disease

Carotid Disease Trials
Aortic Aneurysm Trials
Lower Extremity Arterial Disease Trials
Venous Stasis Ulcer Trials
Iliac Stenting Trials
Drug Trials
Contact Information For All Trials

Carotid Disease Trials

Trial/Sponsor: ACT I/Abbott: Objective:
To demonstrate equivalence of carotid artery stenting using the Xact RX stent w/ the Emboshield Cerebral Protection System Compared to CEA.; Patient Study Population:
Asymptomatic subjects with carotid stenosis ≥80% and ≤99% stenosis.; Investigators:
William Gray, MD and Y. Pierre Gobin, MD

Trial/Sponsor: CHOICE/Abbott: Objective:
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.; Patient Study Population:
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.; Investigators:
James McKinsey, MD and William Gray, MD

Trial/Sponsor: CREATE/ev3: Objective:
To confirm the safety and effectiveness of the PROTEGE ® GPS™ and PROTEGE® 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.; Patient Study Population:
High Risk for CEA, Symptomatic >50% carotid stenosis, Asymptomatic >80% carotid stenosis.; Investigators:
John Karwowski, MD

Trial/Sponsor: EMPIRE: Objective:
Study of GORE Neuro Protection System in carotid stenting.; Patient Study Population:
Patients at high risk for carotid endarterectomy.; Investigators:
William Gray, MD

Trial/Sponsor: SAPPIRE/Cordis: Objective:
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).; Patient Study Population:
High Risk for CEA, Symptomatic >50% carotid stenosis, Asymptomatic >80% carotid stenosis.; Investigators:
Rajeev Dayal, MD

Trial/Sponsor: SMART/Abbott: Objective:
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.; Patient Study Population:
Patients with >70% carotid stenosis.; Investigators:
Ken Perrine, MD and Y. Pierre Gobin, MD

Aortic Aneurysm Trials

Trial/Sponsor: Priceless/Cardiomems: Objective:
To compare data obtained from the EndoSure Wireless AAA Pressure Sensor with data from CT imaging to establish parameters to identify Type I and Type III endoleaks during post-implant follow-up.; Patient Study Population:
Patients who have undergone endovascular repair of abdominal aortic aneurysm with EndoSure Wireless AAA Pressure Sensor implantation.; Investigators:
John Karwowski, MD

Trial/Sponsor: PYTHAGORAS/Lombard: Objective:
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.; Patient Study Population:
AAA >4.5cm in diameter, OR 4.0cm or larger in diameter if symptomatic, OR AAA growth of >5mm within the previous six months, and/or including extension into common iliac artery, and/or Iliac aneurysm >3.5cm in max diameter.; Investigators:
James McKinsey, MD

Trial/Sponsor: Vitality/Medtronic (Pending Approval): Objective:
To examine the long-term safety and effectiveness of the Talent Abdominal Stent Graft System in a post-approval environment.; Patient Study Population:
Abdominal aortic aneurym amenable to repair using the Talent Abdominal Stent Graft System.; Investigators:
James McKinsey, MD

Trial/Sponsor: Zenith® Fenestrated AAA Endovascular Graft Single-Center Study/Cook: Objective:
To assess safety and effectiveness and examine in detail the effect of fenestrated stent-graft technology on organ and extremity perfusion; Patient Study Population:
Patients at high risk for open surgery with abdominal aortic aneuyrsms that are not amenable to endovascular repair using a commercially available stent graft; Investigators:
James McKinsey, MD

Trial/Sponsor: Zenith® Low Profile AAA Endovascular Graft Clinical Study/Cook, Inc.: Objective:
To evaluate the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft. The primary safety endpoint will be the 30-day major adverse event rate and the primary effectiveness endpoint will be device success at 12 months.; Patient Study Population:
Patient Study Population: Patients with AAA with anatomy not suitable for standard EVAR treatment and Iliac/femoral anatomy that can be accessed with a 16 Fr (6mm nominal sheath O.D.) introduction system; Non-aneurysmal infrarenal neck with a length ≥15mm, and a diameter <28mm and >18mm.; Investigators:
James McKinsey, MD

Lower Extremity Arterial Disease Trials

Trial/Sponsor: STROLL: Objective:
S.M.A.R.T.™ Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease.; Patient Study Population:
Patients with de novo or restenotic lesion(s) of the SFA.; Investigators:
William Gray, MD

Trial/Sponsor: Definitive LE/ev3: Objective:
To evaluate the intermediate and long-term effectiveness of stand-alone SilverHawk device for endovascular treatment of peripheral arterial disease in femoropopliteal and tibial-peroneal arteries.; Patient Study Population:
Patients with ≥50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries. Each discrete target lesion’s length is ≤20cm and the reference vessel diameter is ≥1.5mm and ≤7mm.; Investigators:
Rajeev Dayal, MD

Venous Stasis Ulcer Trials

(None at present)

Iliac Stenting Trials

Trial/Sponsor: Complete SE: Objective:
Percutaneous interventional treatment of iliac artery lesions using the Medtronic Complete Self-Expanding Iliac Stent.; Patient Study Population:
Patients with obstructive iliac atherosclerosis resulting in symptoms of claudication.; Investigators:
William Gray, MD

Drug Trials

Trial/Sponsor: Fer-PAD-001/AMAG Pharmaceuticals: Objective:
To assess the sensitivity and specificity of ferumoxytol VE-MRI in detecting lesions or iliac and SFA arteries as seen in angiography.; Patient Study Population:
Patients with intermittent claudication or ischemic rest pain with a resting ABI ≤0.9 and who have been schedule for digital substraction angiography (DSA).; Investigators:
Nicholas Morrissey, MD

Contact Information For All Trials

For more information or to enroll a patient, please contact one of our study coordinators.
Study Coordinators
Trials under Drs. James McKinsey, Nicholas Morrissey, or Rajeev Dayal: Study Coordinator: Diana Catz - (212) 342-4102
Trials under Dr. William Gray: Study Coordinators:
Miriam Lucca-Susana (EMPIRE) - (212) 342-3682
Ariel Hildago (ACT I) - (212) 342-3485
Diana Wong (Complete SE) - (212) 342 4761
Trials under Dr. John Karwowski: Study Coordinator: Ruchita Mehta - (212) 746-5949
Trials under Dr. Y. Pierre Gobin: Study Coordinator: Kim Salvaggio - (212) 746-0389
Trials under Dr. Issam Moussa: Study Coordinator: Dolores Reynolds - (212) 746-4629