Late-Breaking Endovascular Clinical Trial Results Announced At VIVA 15

Nov 02, 2015, 13:05 ET from VIVA Physicians

 

 

 

 

 

LAS VEGAS, Nov. 2, 2015 /PRNewswire/ -- VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, is excited to announce highly anticipated late-breaking clinical trial results at VIVA 15 hosted at the Wynn Las Vegas.

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

MAJESTIC TRIAL: 12-MONTH RESULTS FOR THE ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Presenter: Prof. Stefan Müller-Hülsbeck, MD
MAJESTIC prospective, single-arm clinical study designed to evaluate the performance of the Eluvia drug-eluting vascular stent system (Boston Scientific Corporation) for treating femoropopliteal artery lesions. Results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent, including those with diabetes, sustained a high patency rate and low MAE rate through 12 months.

DCB TREATMENT FOR PATIENTS WITH LIFESTYLE-LIMITING CLAUDICATION: NEW INSIGHTS FROM THE IN.PACT GLOBAL STUDY IN-STENT RESTENOSIS IMAGING COHORT
Presenter: Marianne Brodmann, MD
Treatment of patients with in-stent restenosis (ISR) remains a challenge. Current strategies are plagued by a high rate of restenosis and the need for repeat interven­tions. The 12-month results from the ISR imaging cohort of the IN.PACT Global study demonstrate remarkable patency and low clinically driven TLR results. These data confirm the safety and effectiveness of the In.Pact Admiral DCB (Medtronic) in the treatment of complex superficial femoral artery lesions in this challenging subset.

TWO-YEAR RESULTS FROM THE IN.PACT SFA HEALTH ECONOMIC STUDY
Presenter: David Cohen, MD, MSc
Recent trials have reported higher rates of primary patency after endovascular treatment of femoropopliteal stenoses with drug-coated balloons (DCBs) compared with standard percutaneous transluminal angioplasty (PTA). Formal cost-effectiveness analyses based upon these results demonstrated that DCB was an economically dominant strategy compared with standard PTA. The In.Pact Admiral DCB (Medtronic) was associated with higher initial costs than standard PTA but improved clinical outcomes and similar vascular-related costs through 2 years of follow-up. In.Pact Admiral DCB appears to be a cost-effective strategy compared with standard PTA for femoropopli­teal disease.

DURABILITY ILIAC AND VISIBILITY ILIAC STUDY: 9-MONTH OUTCOMES OF SELF-EXPANDING VS BALLOON-EXPANDABLE STENTS FOR ILIAC ARTERY STENOSIS
Presenter: John Rundback, MD
This analysis compared the safety and effectiveness outcomes of stenting using self-expanding or balloon-expandable stents for the treatment of iliac artery ste­nosis. There were no significant differences in MAE and patency rates between the DURA-Iliac and VISI-Iliac study groups at 9 months despite differences between study groups. These data confirm the safety and effectiveness and comparative uti­lization patterns for BES and SES in the treatment of iliac artery atherosclerosis.

ENDOVASCULAR AORTIC REPAIR IN ACUTE TYPE B AORTIC DISSECTION: 2-YEAR RESULTS FROM THE VALIANT US-IDE STUDY
Presenter: Ali Azizzadeh, MD
Acute type B aortic dissection complicated by malperfusion or contained rupture carries a high risk of mor­tality. We report 2-year results of thoracic endovascular aortic repair (TEVAR) with the Valiant Captivia thoracic stent graft (Medtronic) in this patient population. Midterm results of the Valiant thoracic stent graft in the treatment of acute type B aortic dissection are encouraging. Longer-term outcomes are needed to assess the durability of TEVAR for this indication.

RESULTS OF THE VISION IDE TRIAL FOR THE PANTHERIS OCT-GUIDED DIRECTIONAL ATHERECTOMY SYSTEM
Presenter: Arne Schwindt, MD
The VISION trial was completed for investigational device exemption (IDE) of the Pantheris optical coher­ence tomography (OCT)–guided directional atherectomy system (Avinger, Inc.) for peripheral artery disease (PAD). The Pantheris system, using real-time OCT guidance for directional atherectomy in PAD, is safe and effective, and produced favorable TLR rates at 6 months.

INTERIM RESULTS OF THE FIRST-IN-MAN CLINICAL STUDY EVALUATING THE MobiusHD DEVICE FOR THE TREATMENT OF RESISTANT HYPERTENSION
Presenter: Malcolm T. Foster III, MD, FACC
The multicenter, open-label, nonrandomized CALM (Controlling and Lowering Blood Pressure with the MobiusHD) (Vascular Dynamics, Inc.) first-in-man United States and European mirrored studies are intended to assess the safety and preliminary efficacy of the implant. Enrollment continues across the CALM studies, and interim findings suggest MobiusHD appears safe and shows promising results in lowering BP in patients with stage 2 resistant hypertension.

ILLUMENATE FIH: 2-YEAR RESULTS FROM THE DIRECT DCB COHORT
Presenter: Prakash Krishnan, MD
Most studies assessing the effectiveness of drug-coated balloons (DCBs) for the treatment of peripheral artery disease have required predilatation of the target lesion with an uncoated angioplasty balloon prior to use of the DCB. These data suggest that Stellarex (Spectranetics Corporation) is effective without predilatation in noncomplex disease. The outcomes are in alignment with the durable outcomes observed in the predilatation cohort.

For a complete schedule of the presentations and information on speakers, and to register to attend in person or virtually, 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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