Additional First Time Endovascular Clinical Trial Results Announced At VIVA15

Nov 03, 2015, 14:38 ET from VIVA Physicians

LAS VEGAS, Nov. 3, 2015 /PRNewswire/ -- VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces highly anticipated late-breaking clinical trial results at VIVA 15 hosted at the Wynn Las Vegas.

Below are highlights of today's late-breaking clinical trial presentations, full summaries can be found at viva.vporoom.com/trial-results:

THREE-YEAR ECONOMIC ANALYSIS OF ENDOVASCULAR INTERVENTIONS TO TREAT FEMOROPOPLITEAL PERIPHERAL ARTERY DISEASE
Presenter: Brian DeRubertis, MD
This study evaluated the 3-year economic impact of five endovascular strategies (percutaneous translumi­nal angioplasty [PTA], bare-metal stents [BMSs], drug-eluting stents [DESs], drug-coated balloons [DCBs], and the Supera interwoven nitinol stent [Abbott Vascular]) for the treatment of femoropopliteal peripheral artery disease (PAD) from the perspectives of the US payer (Medicare) and hospital.

The results of the analysis suggest that the interwoven nitinol stent was associated with the lowest risk of repeat procedures. From the payer perspective, the interwoven nitinol stent was more effective and less costly com­pared to PTA, BMS, DES, and DCB and from the hospital perspective, the stent resulted in the greatest remaining payment per procedure compared to PTA, BMS, DES, and DCB.

ZILVER PTX POSTMARKET SURVEILLANCE STUDY OF PACLITAXEL-ELUTING STENTS FOR TREATING FEMOROPOPLITEAL ARTERY DISEASE IN JAPAN: 24-MONTH RESULTS
Presenter: Hiroyoshi Yokoi, MD
The paclitaxel-coated Zilver PTX stent (Cook Medical) is the first DES approved for the superficial femoral artery. This multicenter, prospective, postmarket surveillance study in Japan evaluates the Zilver PTX stent in real-world patients with complex lesions. This study continues to show positive, long-term out­comes for the Zilver PTX stent in complex lesions.

PERIPROCEDURAL OUTCOMES AFTER CAS WITH 21,000 PATIENTS: THE SAPPHIRE WORLDWIDE STUDY
Presenter: D. Christopher Metzger, MD
Carotid Artery Stenting offers an alternative for revascularization of patients with obstructive carotid artery disease, especially those at high risk for carotid endarterectomy (CEA).  SAPPHIRE Worldwide is the largest prospective trial of CAS patients to date and is performed in a real-world setting with prospective neurologic and cardiac evalu­ation. Results of this trial are consistent with results of the CREST trial and other large registries, add­ing further validation for CAS.

LUTONIX GLOBAL REAL-WORLD REGISTRY: 12-MONTH AND INTERIM 24-MONTH OUTCOMES
Presenter: D. Christopher Metzger, MD
The Global SFA registry is a prospective, global, mul­ticenter, single-arm, real-world registry investigating the clinical use and safety of the Lutonix drug-coated PTA dilatation catheter (Bard Peripheral Vascular).  The Lutonix Global registry demonstrates that the Lutonix DCB is safe and effective in real-world patients, including females. Treatment benefit was also demon­strated at 12 months in subgroups with lesions up to 500 mm, calcified lesions, and CTOs.

PERCUTANEOUS FEMOROPOPLITEAL BYPASS OF LONG-SEGMENT OCCLUSIONS: INTERIM TRIAL RESULTS
Presenter: Dainis Krievins, MD,PhD
This CE Mark trial, being conducted in 12 centers in six countries, is designed to evaluate the safety and effec­tiveness of a novel technique and devices for the perfor­mance of percutaneous bypass of long-segment lesions of the superficial femoral and popliteal arteries. The goal of percutaneous femoropopliteal bypass is to achieve or exceed the durable patency rates associated with surgical bypass, with the minimally invasive technique of a percutaneous endovas­cular procedure. The primary performance endpoint is patency at 6 months, assessed by duplex core lab.

FOUR-YEAR RESULTS OF PIVOTAL STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE OVATION ABDOMINAL STENT GRAFT SYSTEM
Presenter: Manish Mehta, MD, MPH, FACS
This study evaluated 4-year safety and effectiveness outcomes of the US pivotal clinical trial for the Ovation abdominal stent graft system (TriVascular, Inc.) for endovascular repair of abdominal aortic aneurysms (AAAs).  The low-profile delivery system (14 F) combined with a robust aneurysm sealing technology offers an endovascu­lar aneurysm repair (EVAR) treatment option to a broad­er pool of patients. The 4-year results of the Ovation clinical study are encouraging and suggest a safe and effective device for the treatment of AAAs and provide compelling evidence that the Ovation system can expand EVAR access to more patients and improve EVAR outcomes for all patients.

FAST-TRACK ENDOVASCULAR ANEURYSM REPAIR: MIDTERM RESULTS OF THE MULTICENTER LEAST INVASIVE FAST-TRACK EVAR (LIFE) REGISTRY
Presenter: Zvonimir Krajcer, MD
The Least Invasive Fast-Track EVAR (LIFE) registry was developed to determine the clinical utility and cost effec­tiveness of the ultra-low-profile (14 F) Ovation abdominal stent graft (TriVascular, Inc.) platform when used under least-invasive conditions. Preliminary results of the LIFE study are encouraging and demonstrate improved patient outcomes and com­pelling economic data when utilizing the Ovation plat­form and a fast-track EVAR protocol.

AUTOGENOUS ARTERIOVENOUS FISTULA CREATION FOR HEMODIALYSIS ACCESS: PRELIMINARY RESULTS OF THE NOVEL ENDOVASCULAR ACCESS TRIAL (NEAT)
Presenter: Charmaine E. Lok, MD, MSc
Arteriovenous fistulas are the recommended hemodialysis access but are suboptimally used due to matura­tion failure, patients' unwillingness to undergo surgery, and inadequate vessels. A new device, the everlinQ system (TVA Medical, Inc.), allows for a mini­mally invasive method of endovascular fistula (endoAVF) creation using radiofrequency energy.  This prospective multicenter study has enrolled 80 patients.  Preliminary findings indicate that the everlinQ system can create an endoAVF safely with high procedural success and an early low thrombosis rate. Long-term follow-up will reveal the functional patency and clinical utility of the endoAVF.

For a complete schedule of the presentations and information on speakers go to the virtual press kit.

About VIVA Physicians
VIVA's mission is demonstrated through activities such as supporting a multidisciplinary fellowship, collaborating with international vascular symposia, interacting with policy makers, and supporting and contributing to philanthropy www.vivaphysicians.org.  

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SOURCE VIVA Physicians