The authors of the Italian registry stated that a stent-less therapy approach with a drug-eluting balloon and optimal angioplasty provides favourable outcomes and is likely to leave more interventional options open for the future.
Despite significant advances in pharmacotherapy and device technology for percutaneous cardiovascular interventions, the fundamental technique of manually advancing intravascular devices at the patient’s table...
Performing angioplasty with new drug-coated balloons to treat femoropopliteal artery disease results in lower rates of late lumen loss and clinically-driven target lesion revascularisation compared with plain angioplasty at both six- and 12-month follow-up, according to new data.
One-year results of the VIASTAR trial published online in the Journal of the American College of Cardiology suggest that a heparin-bonded covered stent may be superior to bare metal stents in the treatment of long femoropopliteal artery disease.
At the LINC congress, Dierk Scheinert presented the details of a randomised trial that will evaluate the Zilver PTX drug-eluting stent vs. paclitaxel-eluting balloons in symptomatic femoropopliteal artery disease.
For the first time, the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery. In order to supply as many physicians as possible with this new technology, Cook said it is making Zilver PTX available initially in 80mm lengths in 6mm and 7mm diameters.
The CONNECT II global clinical trial is designed to evaluate the safety and efficacy of Ocelot (Avinger), the first-ever chronic total occlusion crossing catheter to use real-time intravascular optical coherence tomography imaging technology.
Results from the PATENT (Photo-ablation using the Turbo-Booster and excimer laser for in-stent restenosis treatment) study presented at LINC 2012 in Leipzig, Germany, indicate 76% freedom from target lesion revascularisation at six months.
Along with earlier results from the 4EVER trial, PEACE I confirms the safety and efficacy of the Pulsar-18 stent with positive patency results, further establishing the benefits of 4 French intervention in treating even more advanced cases of femoropopliteal disease.
A vessel preparation treatment strategy of directional atherectomy prior to drug-coated balloon angioplasty with Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) in long, calcified femoropoliteal...
The application includes data that demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularisation) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.
Patients treated with the Zilver PTX paclitaxel-eluting stent (Cook Medical) have shown 70.7% primary patency in the superficial femoral artery at 36 months compared to 49.1% patency for patients with percutaneous transluminal angioplasty and provisional bare metal stent placement.
Biotronik has announced one-year subgroup results from the investigator-initiated BIOPACT randomised controlled trial (RCT), which were presented by principal investigator Koen Deloose (AZ Sint-Blasius,...
Concept Medical recently announced that the SIRONA randomised controlled trial (RCT)—a head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery—has...
In a series of Podium 1st presentations from world-class faculty, CX 2020 LIVE attendees heard the latest data on peripheral arterial disease management and an evaluation of different types of stents, including...
Intact Vascular has announced the peer-reviewed publication, “Practical applications of Tack implants for infrainguinal dissection repair: A single-centre experience” currently available online, with...
Data from the LOCOMOTIVE registry first-in-man trial investigating the VascuFlex Multi-Loc, B Braun’s multiple stent delivery system, were presented by Klaus Amendt (Diakonissenkrankenhaus, Mannheim,...
Results presented at LINC 2016 revealed no significant difference at 18 months in target lesion revascularisation and sustained clinical improvement between the Lutonix and the IN.PACT drug-coated balloons. Clinical improvement was measured by improvement in Rutherford class from baseline or prior to drug-coated balloon treatment.
The study will evaluate the BioMimics 3D stent system against the performance goals defined by VIVA Physicians for the safety and effectiveness of nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery.
Two-year data from the Mimics study, presented at the late-breaking clinical trials session at the VIVA Symposium, have confirmed that BioMimics 3D provides a significant improvement in long-term primary patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention.
By Thomas Zeller
Following successful first-in-man trials (THUNDER, FEMPAC) using the Paccocath/Cotavance coating technology (Bayer, iopromide & 3µg/m2 paclitaxel), two recently presented major pivotal trials...
HumaGraft is being developed to help provide reliable and robust vascular access for haemodialysis patients with end stage renal disease and to reduce or avoid certain serious complications that arise with the current standards of care associated with the current forms of vascular access for haemodialysis.
Results from a feasibility study conducted in Italy indicate that ultrasound-enhanced paclitaxel delivery inhibits arterial smooth muscle proliferation after balloon angioplasty in peripheral arterial disease.
Data from the LEVANT 2 trial comparing the Lutonix drug-eluting balloon with angioplasty alone in the treatment of peripheral arterial disease show that the primary endpoints of both safety and efficacy were met and superior efficacy and non-inferior safety of Lutonix compared to control angioplasty was demonstrated.
The Excimer laser randomised controlled study for treatment of femoropopliteal in-stent restenosis (EXCITE ISR) showed a 93.5% procedural success rate with laser atherectomy plus percutaneous transluminal angioplasty for the treatment of in-stent restenosis versus 82.7% with percutaneous transluminal angioplasty alone.
A post-market surveillance study of the Zilver PTX drug-eluting stent conducted in Japan has shown positive results with the device in the treatment of femoropopliteal lesions. According to the investigators, the results "confirm the benefit of the Zilver PTX technology".
Two-year follow-up data have shown that BioMimics 3D, a nitinol stent with unique three-dimensional helical geometry, provides an improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention for symptomatic peripheral arterial disease.
Treatment of femoropopliteal lesions with the device reduces late lumen loss with safety comparable to that of control angioplasty, according to LEVANT I trial results published in JACC: Cardiovascular Interventions.
Data presented at a late breaking clinical trials session at VIVA13 show that the 3D helical geometry of the BioMimics stent has demonstrated safety and promising clinical performance at 12 months in patients with femoropopliteal lesions.
Patrice Bergeron, Marseille, France, presented initial results of a new device used in the treatment of peripheral arterial disease at the MEET Congress. The new balloon deploys a microneedle into the adventitia and diffuses anti-inflammatory drug into the arterial wall.
Results from the MIMICS study have shown a 12-month Kaplan Meier estimate of freedom from clinically driven target lesion revascularisation of 91.2% for patients treated with the new BioMimics 3D stent.
"In the SUPERB trial, the Supera stent achieved one-year patency rates not previously achieved in a pivotal trial for any stent placed in the superficial femoral artery (SFA) and proximal popliteal artery," said Kenneth Rosenfield, co-principal investigator of the trial at VIVA 2012.
By Anna Maria Ierardi and Gianpaolo Carrafielo
Endovascular treatment for atherosclerotic obstructions in femoropopliteal arteries is widely used for patients with intermittent claudication and critical...
Results from the CONNECT trial demonstrated that Wildcat (Avinger) was able to cross 89.3% (efficacy) of chronic total occlusions in peripheral artery disease that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile.
The new guidelines are set to recommend an endovascular first strategy, even for TASC D lesions. However, TASC IIb remains unpublished as vascular surgical societies have so far failed to endorse these recommendations. A criticism levelled at TASC has been the "fundamentally flawed" decision to change the lesion categorisation repeatedly, which was described as "shifting the goalposts"
The DUET study, a randomised trial conducted to compare standard catheter-directed thrombolysis vs. ultrasound-accelerated thrombolysis in The Netherlands, has begun enrolment of its 60 thrombo-embolic infra-inguinal disease patients.