Publications by authors named "Joren Callaert"

Background: There is evidence that the treatment of symptomatic femoropopliteal disease with a drug-coated balloon (DCB) effectively inhibits restenosis. However for longer and more complex lesions, "bailout" remains stenting almost inevitable. Although the combination therapy of DCBs and modern bare metal stent (BMS) has not been widely studied, there are indications that this combination therapy is doing better than BMS alone and could be a potential alternative for drug-eluting stent treatment.

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Background: Due to the heterogeneity of literature findings, stent type selection for the endovascular treatment of complex aorto-iliac occlusive disease remains challenging. The BELSTREAM study, a physician-initiated, prospective, multicenter, single-arm study, aims to report the safety and efficacy of the balloon expandable LifeStream Peripheral Stent Graft System (BD, Tempe, Arizona, USA) for the treatment of complex TASC C and D aorto-iliac artery lesions.

Methods: Seventy patients and 133 lesions were included at six Belgian institutions.

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Background: To investigate the long-term efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions.

Methods: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the long-term safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018.

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Background: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed.

Objectives: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries.

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Purpose: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions.

Materials And Methods: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.

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Background: Trochanteric fractures are very common hip injuries often fixed with intramedullary nailing as the recommended treatment. Medial lag screw migration of the intramedullary nail system is an uncommon complication. The objective of this case report is to highlight the importance of optimal reduction in hip fractures and the need for a multidisciplinary approach with vascular assistance in intrapelvic lag screw migration.

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Background: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities.

Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.

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A thyroglossal duct cyst (TGDC) is the result of incomplete degeneration of the thyroglossal duct during gestation. It is the most common type of congenital cyst of the neck, and is usually seen in children. The tumor mostly appears at the midline of the neck and generally causes no symptoms, but the mass typically moves when the patient swallows.

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Background: This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment.

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Background: The aim of this study is to investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions.

Methods: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018.

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To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft ( identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.

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Background: The aim of this study was to investigate the efficacy of the balloon expandable Promus Element and Promus Element Plus stents (both Boston Scientific, Marlborough, MA, USA), coated with everolimus, in the treatment of short, focal infrapopliteal lesions.

Methods: The PREVENT study was a prospective, multicenter, non-randomized, single arm study evaluating the safety and efficacy of the Promus Element and Promus Element Plus stent in the treatment of stenotic or occlusive lesions ≤40 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). A total of 70 study subjects were enrolled in a period of 26 months, between November 2012 and December 2014.

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Background: The EVOLUTION Study is a prospective, non-randomized study, investigating the iVolution stent (iVascular, Barcelona, Spain). The study was conducted at the vascular departments of four hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort.

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Common femoral artery (CFA) atherosclerotic lesions currently remain one of the last limitations for adoption of endovascular repair as the first-line treatment. The bulky, eccentric, heavily calcified character of the CFA plaques, frequent involvement of the femoral bifurcation, easy surgical accessibility and last but not least, favorable long-term outcomes still make CFA disease treatment part of the surgical domain. In the last 5 years, improvement of the endovascular equipment and technical skills of the operators have led to an increase in percutaneous CFA procedures.

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Although evidence supports that the performance of drug coated balloons seems to be lesion complexity independent, it is quite clear that in long lesions, severe calcified lesions and chronic total occlusions, the bail out stent ratio is very high and that the "leaving nothing behind" strategy remains a dream in a lot of our daily cases. On the other side of the spectrum, "full metal jackets" of nitinol stents are creating even more problems. Stent fractures, intimal hyperplasia and reintervention difficulties complicate the recurrent vascular disease treatment.

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Background: According to the guidelines, bypass surgery is still the golden standard treatment in patients with femoropopliteal TASC C and D lesions and life-style limiting claudication or critical limb ischemia. Over the past few decades, endovascular therapy has made great advancements. However, the success rates of surgical and endovascular procedures cannot be directly compared.

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The selection of an optimal vascular access strategy for lower limb endovascular intervention is key for procedural safety and success, and is particularly relevant in diabetic patients, in whom extensive occlusive disease commonly involves the infrapopliteal arteries. Individualizing vascular access requires careful planning, including determining normal and abnormal arterial anatomy; the patient's co-medical conditions, especially renal insufficiency; and review of noninvasive vascular laboratory testing. It is essential to be cognizant of the technical nuances, relative safety, advantages, and disadvantages of each potential access site.

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Introduction: Vascular closure devices (VCDs) are designed to achieve rapid hemostasis during percutaneous coronary and peripheral vascular procedures. Studies demonstrate that VCDs improve time to hemostasis (TTH) and time to ambulation (TTA) in comparison to standard manual compression. The available products, however, typically have 13-17 steps in their application, often require hemostatic collagen or other agents as part of the process, and can result in significant scarring at the puncture site that can impact future access.

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Background: The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months.

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Purpose: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long.

Methods: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI).

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Endovascular techniques have improved markedly over the past several decades. Plain old balloon angioplasty can only reach patencies around 40% after 1 year. Scaffolding stents have resulted in improved short-term results but encountered limitations for longer-term durability.

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Purpose: To evaluate the short- and midterm outcomes of the Viabahn endoprosthesis with Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery.

Methods: Between June 2010 and February 2012, 83 patients with superficial femoral artery in-stent and Rutherford category 2 to 5 ischemia were enrolled at 7 sites participating in this prospective randomized controlled study (RELINE; ClinicalTrials.

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Background: The MISAGO ILIAC Study is a prospective, non-randomized, multicenter, bi-national, monitored trial, conducted in 3 hospitals in Belgium and 2 hospitals in Germany. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study was primary patency, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, peak systolic velocity ratio no greater than 2.

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