Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis.

Use of a covered stent after percutaneous transluminal angioplasty (PTA) was compared to PTA alone for treatment of upper extremity hemodialysis patients with arteriovenous fistula (AVF) stenoses. Patients with AVF stenosis of 50% or more and evidence of AVF dysfunction underwent treatment with PTA followed by randomization of 142 patients to include a covered stent or 138 patients with PTA alone. Primary outcomes were 30-day safety, powered for noninferiority, and six-month target lesion primary patency (TLPP), powered to test whether TLPP after covered-stent placement was superior to PTA alone.

Results from the First-in-Human Study of the Caterpillar™ Arterial Embolization System.

Purpose: To assess occlusion success and adverse events associated with the use of a self-expanding device for peripheral artery embolization.

Methods: This prospective, single-arm, feasibility study was conducted using the Caterpillar™ Arterial Embolization Device composed of opposing nitinol fibers and a flow-occluding membrane. Twenty patients (24 embolization sites) were treated at four investigational centers in New Zealand and Australia and followed for 30 days.

Prospective, Multicenter Clinical Study of the Covera Vascular Covered Stent in the Treatment of Stenosis at the Graft-Vein Anastomosis of Dysfunctional Hemodialysis Access Grafts.

Purpose: To study the use of the self-expanding Covera covered stent for the treatment of stenotic lesions at the venous anastomosis of hemodialysis arteriovenous grafts (AVGs).

Materials And Methods: A total of 110 patients with AVG venous anastomotic stenosis of ≥50% and access dysfunction were treated at 14 centers in the United States using percutaneous transluminal angioplasty followed by covered stent placement. The primary end points were 30-day safety and 6-month target lesion primary patency (TLPP).

Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction.

Purpose: To assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction.

Materials And Methods: Twenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%).

Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial.

Objectives: We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions.

Methods: A total of 442 patients with angiographically significant lesions were randomized (2:1) to DCB or PTA. The primary safety and efficacy endpoints were freedom from major adverse limb events and perioperative death (MALE-POD) at 30 days, and freedom from vessel occlusion, clinically driven target-lesion revascularization (CD-TLR), and above-ankle amputation measured at 6 months.

Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study.

Purpose: This study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions.

Methods: A total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months.

Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study.

: To assess the use of a nitinol stent to treat symptomatic stenoses or occlusions of the native superficial femoral artery (SFA). : Seventy-four patients were treated at 12 Japanese sites. The primary endpoint, freedom from target-limb failure (TLF), was a composite of device- or procedure-related death, target-limb amputation, target-vessel revascularization (TVR), or restenosis compared to an objective performance goal (OPG) at 12 months.

The DENALI Trial: an interim analysis of a prospective, multicenter study of the Denali retrievable inferior vena cava filter.

Purpose: To assess safety and effectiveness of a nitinol retrievable inferior vena cava (IVC) filter in patients who require caval interruption to protect against pulmonary embolism (PE).

Materials And Methods: Two hundred patients with temporary indications for an IVC filter were enrolled in this prospective, multicenter clinical study. Patients undergoing filter implantation were to be followed for 2 years or for 30 days after filter retrieval.