Clinical Research and Trials

CURRENT TRIALS

Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI)
Site Principal Investigator: Joe Huang, MD
This NIH-funded, multi-center, randomized trial will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

For more information from clinicaltrial.gov, please click here.

Human Acellular Vessel (HAV) in Patients with Vascular Trauma
Site Principal Investigator: Michael Curi, MD
This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques.

For more information from clinicaltrial.gov, please click here.

Comparison of the Human Acellular Vessel (HAV) with Fistulas as Conduits for Hemodialysis
Site Principal Investigator: Joe Huang, MD
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access. This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative study.

For more information from clinicaltrial.gov, please click here.

Lower Extremity Revascularization Outcomes Assessment
Principal Investigator: Joe Huang, MD
The purpose of this study is to evaluate the efficacy, complications, and outcomes of lower extremity endovascular and open revascularizations in an urban tertiary care facility.

PAST TRIALS

Comparison of the Human Acellular Vessel (HAV) with ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)
Site Principal Investigator: Michael Curi, MD
The main purpose of this randomized study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

For more information from clinicaltrial.gov, please click here.

The SENTRY Clinical Study
Site Principal Investigator: Michael Curi, MD
The purpose of this trial is to determine the clinical success rate of the SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter, which has been developed to provide temporary protection against pulmonary embolism (PE).

For more information from clinicaltrial.gov, please click here.

Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization (DANCE)
Site Principal Investigator: Michael Curi, MD
The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US FDA, can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.

For more information from clinicaltrial.gov, please click here.

EUCLID Trial (Examining Use of tiCagreLor In paD Trial)

Site Co-Investigators: Michael Curi, MD and Joe Huang, MD

This multicenter trial compares a medication called ticagrelor (Brilinta) to clopidogrel (Plavix) and their effects on death from cardiovascular events, myocardial infarction (heart attack), and stroke in patients with known peripheral arterial disease (PAD).

For more information from clinicaltrial.gov, please click here.

Endograft Repair of Aortic Aneurysms Open versus Endovascular Repair of Abdominal Aortic Aneurysm (OVER)
Site Principal Investigator: Frank Padberg, Jr. MD
Patients with AAA >5.0cm are eligible for randomization between these two management strategies. Open repair has a known durable outcome, but requires an abdominal incision with a longer hospital and ICU stay. Endovascular repair is a new therapy which offers reduced immediate post-op effects, but whose durability is, as yet, incompletely defined; since secondary rupture has been reported after endovascular repair, this is not an inconsequential issue. The study is funded by VA Cooperative Studies Program and will continue for 5-8 years from its inception in 2002.

For more information from clinicaltrial.gov, please click here.

TRANSFIX Zenith Transection Clinical Study
Site Co-Investigators: Michael Curi, MD and Joe Huang, MD
The purpose of this multicenter study is to examine the safety and effectiveness of the Zenith TX2 Low Profile Endovascular Graft for treatment of blunt thoracic aortic injury.

For more information from clinicaltrial.gov, please click here.

Carotid Revascularization-Endarterectomy versus Stent Trial (CREST)

While rapidly expanding in its use, carotid artery stenting (CAS) remains a relatively new procedure. Its growth is due, at least in part, to the perceived advantages of a less invasive technique. However, the clinical effectiveness of CAS has not been established, and relatively little data has been reported on morbidity and mortality associated with specific devices and techniques. The aim of this NIH funded clinical trial, Carotid Revascularization Endarterectomy vs. Stent Trial (CREST), is to contrast the relative efficacy of CAS versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction or death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period (extending up to four years) in patients with symptomatic extracranial carotid stenosis. The results of this landmark trial were published in the New England Journal of Medicine (NEJM) in 2010.

Guidant Acculink ® stent and Accunet® anti-embolism device being used in the CREST trial.

Useful links:

• More information on carotid stenosis.
• CREST carotid stenting trial.
• Society for Vascular Surgery: www.vascular.org
• American Stroke Association: www.stroke.org

Lower Extremity Revascularization After Soft Tissue Tumor Resection
Principal Investigator: Joe Huang, MD
The purpose of this study is to examine revascularization procedures in patients who undergo resection of lower extremity sarcomas that involve major vessels. The study will provide insight into the short and long term outcomes of lower extremity revascularization in this specific patient population.

IVC Filter Retrieval in Sarcoma Patients
Principal Investigator: Michael Curi, MD
The purpose of this study is to determine the rates of vascular complications following retrievable inferior vena cava (IVC) filter placement and the removal/retrieval rate of these filters in patients evaluated and treated at our institution.

Clinical Significance of Incidental Vascular Pathology Found on Trauma CT Scans
Principal Investigator: Joe Huang, MD
The purposes of this investigation are to determine: (1) what is the frequency of incidental vascular findings discovered on CT scans performed for traumatic injury at our center, (2) how clinically significant are these findings, (3) how often is documented referral to inpatient workup or outpatient follow up performed, and (4) whether any difference exists in outcomes based on the adequacy of evaluation or follow up for incidental vascular findings during management of patients for trauma.