Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: Tack Optimized Balloon Angioplasty (TOBA) III 24-month results in standard and long lesions.

Objective: The Tack Endovascular System is a minimal-metal dissection repair device that is purpose-built to treat post-percutaneous angioplasty (PTA) arterial dissections in patients with peripheral arterial disease (PAD). The Tack Optimized Balloon Angioplasty (TOBA) III trial evaluated the safety and effectiveness of the Tack Endovascular System in patients with superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) dissection after PTA with a drug-coated balloon (DCB). The objective of this study is to report the results in the standard- (SL) and long-lesion (LL) cohorts through 24 months.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.

Objectives: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval.

Methods: Prospective, single-arm, multicenter study with 24 months follow-up.

Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial.

Background: So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies.

Objectives: The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

Purpose: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).

Materials And Methods: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA).

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial.

Purpose: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries.

Materials And Methods: This prospective, multicenter, single-arm trial (; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.

Tibiopedal and distal femoral retrograde vascular access for challenging chronic total occlusions: predictors for technical success, and complication rates in a large single-center cohort.

Objective: To evaluate the safety and effectiveness of tibiopedal and distal femoral access for retrograde crossing of chronic total occlusion (CTO) in Rutherford stage III to VI peripheral arterial occlusive disease, and to determine factors that correlate with technical success.

Material And Methods: One hundred seventy-one consecutive patients were included in this retrospective study. Rutherford stages were III, IV, and V/VI in 24%, 8%, and 67% of patients.

Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions.

To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.

Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results.

Objective: The Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty.

Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial.

Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016.

Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial.

To investigate the efficacy and sustainability of drug-coated balloon (DCB) treatment of femoropopliteal in-stent restenosis (ISR). An investigator-initiated, prospective, multicenter, 1:1 randomized study enrolled 88 patients for treatment of ISR with DCB (n=47; mean age 68.3±9.

COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.

Aims: Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs.

Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial.

Aims: Although paclitaxel drug-coated balloon (DCB) angioplasty is an established endovascular treatment for peripheral artery disease, restenosis remains a major concern. Thus, we compared a novel paclitaxel-coated DCB with nano-coating technology with uncoated plain old balloon angioplasty (POBA).

Methods And Results: This multicentre trial randomly assigned 171 patients with stenotic and occlusive lesions of the femoropopliteal artery to angioplasty with a novel DCB or uncoated POBA.

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial.

Objectives: Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted.

The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial.

Background: The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U.

[Management of complications after revascularization due to peripheral arterial occlusive disease : Prophylaxis and consistent adequate therapy after timely diagnostics].

Background: Complications are a threat to successful revascularization for treatment of perpheral arterial occlusive disease (PAOD) and must, therefore, be either primarily prevented or effectively treated after having occurred.

Objectives: The aim of this article is to give a survey of possible complications after revascularization for treatment of PAOD and their management.

Material And Methods: A systematic literature review was performed in PubMed and Medline.

Portal vein recanalization and embolization of the transsplenic puncture tract using an Amplatzer® vascular plug: a case report.

Background: A transsplenic access for the catheterization of the portal venous system to treat a portal vein thrombosis and/or stenosis entails the risk of intra-abdominal or intrasplenic bleeding complications and has to be seen as an approach of last resort. This is one of few reported cases in the literature where a transsplenic puncture tract was successfully embolized using an Amplatzer® vascular plug 4 (8 mm; St. Jude Medical).

Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial.

Objectives: The purpose of this study was to evaluate the 5-year follow-up (FU) data of the THUNDER (Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries).

Background: The THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon (PCB).

Methods: In 154 patients, femoropopliteal arteries were treated with PCB, with angioplasty with paclitaxel in contrast medium, or no paclitaxel (control).

Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial.

Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.

Endovascular aneurysm repair of abdominal aortic aneurysms: standards, technical options and advanced indications.

Unlabelled: Since the introduction of endovascular aneurysm repair (EVAR) in 1991, the endovascular therapy with newest stent grafts has assumed a prominent role in the clinical management of abdominal aortic aneurysms (AAA) with a superior perioperative mortality of EVAR and an equivalent mid-term outcome, compared to open surgery. Newest techniques using chimney or periscope grafts and customized fenestrated and branched stent grafts allow the endovascular treatment of complex pararenal AAA. This article reviews EVAR in the treatment of AAA, evidence based results and advanced indication by newest interventional techniques and technical developments.

High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study.

Purpose: To investigate the impact of using paclitaxel-coated balloons (PCB) on outcome after post-angioplasty dissection in femoropopliteal arteries.

Methods: The angiograms obtained in the THUNDER study (ClinicalTrials.gov identifier NCT00156624) were analyzed to compare degrees of dissection and angiographic parameters between the control (uncoated balloons, n=43) and treatment (PCBs, n=43) groups before and after the intervention and at 6-month follow-up.

Perfusion measurements of the calf in patients with peripheral arterial occlusive disease before and after percutaneous transluminal angioplasty using MR arterial spin labeling.

Purpose: To evaluate muscle perfusion in patients with peripheral arterial occlusive disease (PAOD) before and after percutaneous transluminal angioplasty (PTA) of the limb by means of MR arterial spin labeling (ASL) perfusion measurements during reactive hyperemia.

Materials And Methods: Ten patients with symptomatic PAOD affecting the iliac or femoral vessels were investigated before and after PTA. A pseudo-continuous arterial spin labeling (PCASL) MR technique was applied.

Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease.

Purpose: To present the 12-month results of a trial investigating the effects of dual antiplatelet therapy on target lesion revascularization (TLR) after balloon angioplasty ± stenting in the femoropopliteal segment.

Methods: A prospective, randomized, single-center, double-blinded and placebo-controlled clinical trial randomly assigned 40 patients to receive pre- and postinterventional therapy with aspirin and clopidogrel. Another 40 patients received the same doses of aspirin and placebo instead of clopidogrel.

Hybrid debranching and TEVAR of the aortic arch off-pump, in re-do patients with complicated chronic type-A aortic dissections: a critical report.

Background: Patients suffering from acute type A aortic dissection undergo replacement of the ascending aorta, the proximal hemiarch or complete aortic arch, depending on the extent of the individual pathology. In a subset of these treated patients, secondary pathologies of the distal anastomosis or the remaining distal part of the aorta occur. The treatment of these pathologies is challenging, requiring major surgical re-do procedures with aortic arch replacement under extracorporeal circulation and hypothermic circulatory arrest.

[Renal failure and recurrent episodes of flash pulmonary edema in a 70-year-old patient].

History And Admission Findings: We report on a patient presenting with renal failure who developed mutliple episodes of flash pulmonary edema.

Investigations: Volume retention due to ischemic nephropathy was found to be the cause.

Diagnosis, Treatment And Course: She was diagnosed to have a high grade renal artery stenosis in a functional solitary kidney and underwent percutaneous angioplasty.