To evaluate whether the ultrasound subset was representative of the entire patient population, the demographics, comorbidities, lesion characteristics, 12-month freedom from TLR rates, and 12-month freedom from thrombosis rates for patients who underwent ultrasound were compared with those for patients who did not undergo ultrasound, and no significant differences were found. Scratches evident on the tip surface more than likely were caused by the fractured portion of the stent. The ir thought the safest thing to do was just leave it alone. Twelve-month follow-up was obtained for 787 patients, representing >95% of those eligible.
. Find out more at www.cookmedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn. . The stent is fully deployed when the handle (a) reaches the hub (b). Balloon angioplasty was conducted and upon review of the images angioplasty was confirmed to be successful, but ir wanted to place a stent there as well more distally to cover up some additional disease. :

Continuous variables were summarized with means and SD, with p values calculated using the standard t test. The physician was convinced that this second injury was caused by the closure device since there was some difficulty deploying the angioseal device. This multicenter, prospective, post-market surveillance study planned to enroll the first 900 consecutive patients with symptomatic PAD involving the above-the-knee femoropopliteal arteries who were treated with the Zilver PTX Drug-Eluting Peripheral Stent (Cook Medical, Bloomington, Indiana) in Japan. At longer times since the study procedure, the likelihood that the occlusions were of restenotic rather than thrombotic origin increases. Delivery System: Outer Sheath Delivery System: Inner Catheter Figure 18 4. :

Off label activities and failure to observe recommendations in the ifu were noted, such as stent placement in the iliac artery instead of femoropopliteal artery, delivery system was not removed despite resistance encountered during advancement and delivery system was pushed with force during device advancement. :

After some difficulty trying to cross the lesion, radiologic technician (rt) asked ir if he would like to try an "up and over sheath. Ohki T., Yokoi H., Kichikawa K.et al. "1-year results of the ZEPHYR registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis" Jaff M., Dake M., Popma J., Ansel G. and Yoder T.:

The second arterial injury above the puncture site is of unknown etiology. 13. Not all products shown on this website may be approved in all regulatory jurisdictions. Similarly, the mean ABI also significantly improved at 12 months from 0.63 to 0.86. Pusher ring was also examined and indentation was evident on the distal edge of the pusher ring. Jaff M., Dake M., Popma J., Ansel G. and Yoder T. "Standardized evaluation and reporting of stent fractures in clinical trials of noncoronary devices", "Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery", "Endovascular stenting of superficial femoral artery stenosis and occlusions: results and risk factor analysis", "Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial", "PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study", "Results of the Protege EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions", "Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials", "1-year results of the ZEPHYR registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis", "Nitinol self-expanding stents vs. balloon angioplasty for very long femoropopliteal lesions", "Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease)".

(Zilver PTX Post-Market Study in Japan; NCT02254837). J Am Coll Cardiol Intv2013; 6: 282. Remove the delivery system and replace with a new device. Department of Cardiovascular Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan, Department of Surgery, Jikei University Hospital, Tokyo, Japan, Department of Radiology, Nara Medical University, Kashihara, Japan, Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center, Tokyo, Japan, Division of Vascular Surgery, Division of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan, Nishinomiya Hospital Affairs, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan, Cook Research Incorporated, West Lafayette, Indiana, Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, California.
He requested a 6x80 zilver ptx stent and was informed of the sfa indication associated with zilver ptx. From the information provided, it can be noted that delivery system was not advancing easily due to the patient's heavily calcified anatomy. Dr. Nakamura has received consulting fees for this post-market study (Cook Japan) and Terumo; and has received speaking fees for Cook Japan, Terumo, Cordis Japan, and Medico. The low frequencies of stent fracture and thrombotic occlusion after DES placement reported in the present study are comparable to the published rates for nitinol BMS and to previous reports with the DES (1,2,5–10). Using the microscope, pusher ring and the tip was examined. Post-treatment clinical benefit, defined as freedom from persistent or worsening symptoms of ischemia (i.e., claudication, rest pain, ulcer, or tissue loss), was 87.7% at 12 months (Figure 2). This study was sponsored by Cook Medical. The ir stated ''i've almost got it" and began trying to advance the stent again. J Endovasc Ther2011; 18: 613. Additionally, risk factors beyond the stented lesion, for example, untreated residual inflow or outflow stenosis or poor runoff, may contribute to the potential for thrombosis within the infrainguinal arteries.

© 2020 American College of Cardiology Foundation. : Demographics and Lesion Characteristics.

Refer to the Instructions for Use (IFU) for full prescribing information including information on potential adverse events, contraindications, warnings, precautions, and summary of clinical data. Zilver ptx delivery catheter would not track over the bifurcation and the operator continued advancement after repositioning the sheath resulted in buckling of the delivery system which was confirmed on evaluation of the returned device. WHAT IS NEW? The 12-month patency rate from the current study also compares favorably to the patency rates, ranging from 51.1% to 78.0%, reported for atherectomy (20,21). . the cr received the damaged product from the sterile field and began to examine the tip of the device. Clinical improvement of at least 1 Rutherford class was achieved in 638 of 757 patients (84.3%), ∼80% of patients were classified as Rutherford class 0 or 1 at 12 months, and the median Rutherford classification improved from class 3 to class 0 (Table 2). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Welcome to the newly redesigned JACC.org. Between May 2012 and February 2013, 907 patients were enrolled at 95 institutions in Japan. The first zilver ptx partially deployed with the distal end of the stent fracturing such that it remained in the target lesion. As a result, patency through 12 months was evaluated for a subset of approximately 65% (702 1,075) of lesions. . "Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial" The white tip was examined and it was evident that the tip had been severely deformed.


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