Vascular Clinical Trials

Vascular

An operating room at NewYork-Presbyterian with the Siemens Artis zeego® medical imaging system.

About Vascular Clinical Trials

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
Access to Hemodialysis
Iliac Aneurysm Trials
Iliac Stenting Trials
Vena Cava Filter
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: 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: Zenith Low Profile AAA Endovascular Graft/Cook: 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:
Patients with AAA with anatomy not suitable for standard EVAR treatment and - Iliac/femoral anatomy that can be accessed with a 16 Fr (6 mm nominal sheath O.D.) introduction system; - Non-aneurysmal infrarenal neck with a length greater than or equal to 15 mm, and a diameter < 28 mm and > 18 mm.; Investigators:
James F. 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® Fenestrated AAA Endovascular Graft Multi-Center Study/Cook: Objective:
To evaluate the safety and effectiveness of the Zenith Fenestrated AAA Endovascular Graft in the treatment of subjects with abdominal aortic aneurysms with a short infrarenal aortic neck; Patient Study Population:
To evaluate the safety and effectiveness of the Zenith Fenestrated AAA Endovascular Graft in the treatment of subjects with abdominal aortic aneurysms with a short infrarenal aortic neck; Investigators:
Darren Schneider, MD

Lower Extremity Arterial Disease Trials

Trial/Sponsor: OSPREY /Terumo: Objective:
A Multi-center clinical trial of efficacy and safety of the the MisagoTM Self Expanding Stent System for subjects with Superficial Femoral Artery (SFA) lesions up to 16 cm.; Patient Study Population:
Patients with de novo or restenotic lesion(s) of the SFA will be invited to participate. Lesions should have reference vessel diameters ranging from 4.0 to 7.0 mm and at least one vessel runoff.; Investigators:
James F. McKinsey, MD

Trial/Sponsor: FINEST/MAQUET Cardiovascular,LLC: Objective:
To evaluate the safety and efficacy of the FUSION™ Vascular Graft and the FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCELTM Soft ePTFE in subjects in need of a femoropopliteal bypass.; Patient Study Population:
Patient requires femoral popliteal (above-knee) bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery.; Investigators:
Nicholas J. Morrissey, MD, John Karwowski, MD

Trial/Sponsor: MarrowStim PAD kit/Biomet Biologics: Objective:
The purpose of this trial is to evaluate the ability of the MarrowStim PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.; Patient Study Population:
Patients with unilateral or bilateral lower extremity ischemia due to advanced peripheral arterial disease who have no revascularization options that may otherwise be facing amputation.; Investigators:
John Karwowski, MD

Trial/Sponsor: LEVANT-2: Objective:
A Prospective, Multicenter, Single Blind, Randomized,Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries; Patient Study Population:
Patients with de novo or restenotic lesion of between 4-15 cm in SFA or popliteal will be invited to participate. Lesions should have at least one vessel runoff; Investigators:
James F. McKinsey, MD

Access to Hemodialysis

Trial/Sponsor: ACUSEAL/ W.L.GORE: Objective:
The purpose of this study is to establish safety and efficacy of the GORE ACUSEAL Vascular Graft for use in hemodialysis at any time post- implantation.; Patient Study Population:
End-Stage Renal Disease (ESRD) patients either currently receiving hemodialysis or expected to require hemodialysis through a prosthetic vascular access graft within 30 days.; Investigators:
Nicholas J. Morrissey, MD

Iliac Aneurysm Trials

Trial/Sponsor: PRESERVE - Zenith Iliac Branch System Clinical Study/Cook, Inc.: Objective:
The purpose of the study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the Zenith® Connection Endovascular Covered Stent.; Patient Study Population:
Patients with an aortoiliac or iliac aneurysm and an unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery on the intended side of Branch Graft implantation (e.g., fixation/seal length < 10 mm or diameter > 20 mm); Investigators:
Darren Schneider, MD, James McKinsey, MD

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

Vena Cava Filter

Trial/Sponsor: Denali Filter /Bard Peripheral Vascular: Objective:
This is a Prospective, Multi-Center Study which intended to provide evidence of safety of the placement and retrieval of the Bard Denali Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to protect against pulmonary embolism (PE).; Patient Study Population:
Patient with increased risk of pulmonary embolism who require vena cava interruption will be invited to participate. Retrieval of the filter is expected within 180 days post placement; Investigators:
Danielle Bajakian, 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 or Nicholas Morrissey: Study Coordinator: Diana Catz - (212) 342-4102
Trials under Dr. William Gray: Study Coordinator: Angelica Castaneta - 212-342-3490
Trials under Drs. John Karwowski, Darren Schneider: Study Coordinator: Ruchita Mehta - (212) 746-5949
Trials under Dr. Y. Pierre Gobin: Study Coordinator: Kim Salvaggio - (212) 746-0389