Durability trial sfa

This reflects the times in which we live; without appropriate longer-term postmarket surveillance, certain potential safety issues may not become evident to us. I agree that the follow-up is arduous and expensive, but that is balanced by safety issues.

How can we do this more uniformly and at a lower cost? CMS has very huge databases, and physicians have not engaged those databases to look at potential safety megatrends in this population; it is about time that this option is considered. The cm stent is not yet available on the market. There are cm stents that have been made available through the k regulatory pathway; they are used "off-label" in the vasculature by physicians.

These stents are manufactured by IDev, Cordis, Medtronic, and ev3. However, we need to evolve beyond this k biliary stent paradigm; this is a regulatory pathway, used by industry, in order to provide doctors with these technologies. The unintended consequence is that we now have millions of stents being placed in patients without a thorough understanding of the clinical effectiveness or the long-term safety profile of these devices in the various vascular beds in which they are being deployed.

Industry, physicians, and the FDA must work together to investigate ways to obtain such data without stifling trial execution and innovation.

The present regulatory environment will cause industry members to invest resources elsewhere, much to the determinant of our society. They must work together to answer these questions sooner rather than later. VIVA Physicians wants to be part of the solution and not the problem by setting out the Performance Goals and encouraging industry's involvement.

When we look back, this will be a landmark trial in many ways. Rocha-Singh may be reached at ; ksingh prairieheart. Previous Article. Next Article right-arrow Created with Sketch. With Robin H. With Dejah R. Judelson, MD; Brian M. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery SFA and proximal popliteal artery.

The study's primary end points were the day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals.

A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. He is a compensated consultant for Abbott Vascular.

Dr Snead, B. Alexander, and M. Landini are full-time employees of Medtronic. The other authors report no conflicts. The clinical data from the IN. PACT SFA Trial, which was designed as a 2-phase, global, multicenter, single-blind, randomized trial, provide valid scientific evidence to conclusively demonstrate the effectiveness and safety of the IN.

The significant sustained clinical improvement, the low rate of clinically driven target lesion revascularization, the absence of amputation, and the minimal incidence of thrombosis observed in the IN. PACT SFA Trial data demonstrate an important therapeutic advantage over the existing alternative treatments for peripheral artery disease. DCB is an attractive alternative, because it offers the promise of improved patency in comparison with percutaneous transluminal angioplasty and a reduction in the need for stents.

This is particularly important in the dynamic environment of the superficial femoral and popliteal arteries, where mechanical fatigue may lead to stent fracture and the increased risk of in-stent restenosis.

The results of this trial support DCB as an important treatment option for patients with superficial femoral and popliteal artery disease. National Center for Biotechnology Information , U.

Published online Feb 2. Jaff , DO, for the IN. Author information Copyright and License information Disclaimer.

Corresponding author. Correspondence to John R. E-mail ude. Circulation is published on behalf of the American Heart Association, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.

This article has been cited by other articles in PMC. Abstract Background— Drug-coated balloons DCBs have shown promise in improving the outcomes for patients with peripheral artery disease. Methods and Results— The IN. Conclusions— In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease.

Keywords: drug-eluting balloons, peripheral arterial disease, peripheral vascular diseases. Clinical Perspective on p One approach to this challenge has been the development of the drug-coated balloon DCB , which combines balloon dilatation with local delivery of an antiproliferative drug. Randomization and Blinding Randomization occurred after successful crossing of the lesion in the IN.

Open in a separate window. Figure 1. Treatment and Medical Therapy Patients randomly assigned to the experimental arm were treated with the IN. Follow-Up For the primary end point analysis, patients were followed by the treating physician at 30 days, 6 months, and 12 months, including office visits with duplex ultrasonography functional testing and adverse event assessment. Role of the Funding Source The trial was designed by the principal investigators G.

Table 1. Table 2. Key Clinical and Safety Outcomes. Figure 2. Safety Outcomes There were no procedure- or device-related deaths and no major amputations through 12 months in either arm. Functional Outcomes At 12 months, there was no significant difference between treatment groups in the change from baseline in quality-of-life by using the EQ-5D assessment, but the results trended in favor of IN.

Discussion In this trial, the IN. Study Limitations The trial was deliberately and prospectively conducted in 2 sequential phases. Conclusions In conclusion, in this large, prospective, multicenter, international, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic superficial femoral and proximal popliteal artery PAD.

Source of Funding The study was funded by Medtronic, Inc. References 1. J Vasc Surg. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology ESC.

Eur Heart J. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. Previous Article. Next Article right-arrow Created with Sketch. LinkedIn Created with Sketch. Current Issue. Related News.