86 research outputs found

    Intravascular Ultrasound and Peripheral Endovascular Interventions

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    In recent years the interest in minimal invasive surgery has been growing and the same trend can be observed in vascular surgery, leading to what is commonly referred to as lIendovascular surgery". Although the 1990s represent an era of technical revolution in vascular surgery, it is a misunderstanding to consider endovascular treatment a recent development. In 1947 J050 Cid dos Santos described the thrombo-endarterectomy'; this technique was modified by Vollmar in 1964, to a semi-closed endarterectomy using ringstrippers'> In the same year other pioneers, including Dotter and Judkins, published prelinlinary results on what they called "angioplasty" of the femoropopliteal artery using coaxial eatheters.3 This technique was later modified by Griintzig in 1974, who replaced the coaxial catheters with dilatation balloons.' In the early 1990s, Volodos and Parodi introduced the endovascular treatment of the abdominal aortic aneurysm with a device composed of a Dacron graft and Palmaz stents.5 ,6 The collaboration between interventional radiologists and vascular surgeons has been of eminent importance for further evolution of endovascular teclmiques. Nowadays a great variety of obstmctive and aneurysmal peripheral vascular diseases can be treated with catheter-guided, endovascular and, therefore, less invasive techniques. The development of these endovascular techniques prompted the need for improved vascular imaging and better diagnostics. Since angiography displays only a "lumenogram II of the vessel, tills prechldes qualitative evaluation of atherosclerotic plaque and quantitative assessment of plaque and vessel. Sophisticated modalities such as colour duplex, computed tomographic angiography and magnetic resonance imaging can be important in the pre- and postintervention assessment of vascular disease. These techniques, however, do not always give accurate information on the dimensions of the vessel or the extent of the disease and at the present time cannot be used during intervention.7 Intravascular ultrasound depicts both the vascular lumen and vascular wall: thus, information can be obtained on the atheromatous plaque constituents and the size of the lumen, vessel wall and arterial disease

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    Standardized definitions and clinical endpoints in trials investigating endovascular repair of aortic dissections.

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    OBJECTIVES Endovascular therapy is a rapidly expanding option for the treatment of patients with aortic dissection (AD) and various studies have been published. These trials, however, are often difficult to interpret and compare because they do not utilize uniform clinical endpoint definitions. METHODS The DEFINE Group is a collaborative effort of an ad hoc multidisciplinary team from various specialties involved in AD therapy in Europe and the United States. DEFINE's goal was to arrive at a broad based consensus for baseline and endpoint definitions in trials for endovascular therapy of various vascular pathologies. In this project, which started in December 2006, the individual team members reviewed the existing pertinent literature. Following this, a series of telephone conferences and face-to-face meetings were held to agree upon definitions. Input was also obtained from regulatory (United States Food and Drug Administration) and industry (device manufacturers with an interest in peripheral endovascular revascularization) stakeholders, respectively. RESULTS These efforts resulted in the present document containing proposed baseline and endpoint definitions for clinical and morphological outcomes. Although the consensus has inevitably included certain arbitrary consensus choices and compromises, adherence to these proposed standard definitions would provide consistency across future trials, thereby facilitating evaluation of clinical effectiveness and safety of various endovascular revascularization techniques. CONCLUSIONS This current document is based on a broad based consensus involving relevant stakeholders from the medical community, industry and regulatory bodies. It is proposed that the consensus document may have value for study design of future clinical trials in endovascular AD therapy as well as for regulatory purposes
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