A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial.

Background: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation.

Methods And Results: SB were coated with paclitaxel admixed with a specific excipient.

Inhibition of neo-intimal hyperplasia in porcine coronary arteries utilizing a novel paclitaxel-coated scoring balloon catheter.

Objective: Scoring balloons are particularly useful in the acute treatment of fibro-calcific, bifurcation and in-stent restenosis lesions but have not been shown to affect the restenosis rate. Conventional balloons coated with paclitaxel have recently been shown to reduce restenosis rates in certain lesion subsets, but are associated with suboptimal acute results. A novel paclitaxel-coated scoring balloon was developed to overcome these limitations.

A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: final results of the AGILITY trial.

Background: The provisional approach for bifurcation stenting with side-branch balloon angioplasty is associated with dissections and suboptimal results requiring kissing balloon techniques or bailout stenting. We hypothesized that using a scoring balloon for the side branch and a drug-eluting stent for the main vessel might improve outcomes of true bifurcation lesions.

Methods And Results: A total of 93 patients with complex bifurcations were enrolled in a multicenter, single-arm, prospective clinical trial.

Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease.

Objective: To evaluate the AngioSculpt (ASC), a novel scoring balloon catheter designed to treat complex diffuse fibro-calcific atherosclerotic lesions and avoid device slippage during deployment, in patients with infra-popliteal disease.

Methods: The ASC incorporates a flexible nitinol scoring element containing three or more spiral struts which encircle a minimally compliant balloon to create focal concentration of the dilating force. Patients scheduled for percutaneous intervention of infra-popliteal arteries or planned amputation and with a reference vessel diameter of 1.

Impact of the Duett sealing device on quality of life and hospitalization costs for coronary diagnostic and interventional procedures: Results from the Study of Economic and Quality of Life substudy of the SEAL trial.

Background: The Simple and Effective Arterial Closure (SEAL) trial examined the safety and effectiveness of the Duett vascular sealing device (Vascular Solutions, Minneapolis, Minn) versus manual compression after diagnostic and interventional coronary procedures. We compared quality of life and initial hospitalization costs among patients treated with the Duett device versus manual compression.

Methods: Functional status was assessed with the Duke Activity Status Index (DASI) at 7 and 30 days after intervention.

Arterial access site closure with a novel sealing device: Duett.

Management of arterial access sites following percutaneous endovascular procedures is associated with patient discomfort and local complications. A new vascular sealing device, comprised of a balloon delivery catheter and a flowable procoagulant consisting of thrombin and collagen, was tested. Immediately following catheterization 200 patients (age, 66.

Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: initial U.S. feasibility trial using the Duett vascular closure device.

The aim of this first U.S. feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, Duett, following percutaneous endovascular procedures.

Final report of the European multi-center registry using the Duett vascular sealing device.

Duett, a novel vascular sealing device, was first clinically used in July 1997. A European multi-center registry was established to evaluate the safety and procedural success of the Duett sealing device in a broad range of patients undergoing diagnostic or interventional endovascular procedures. At 25 European sites 1587 patients were enrolled.

The Duett closure device: concept and experimental results.

Purpose of this paper is to investigate the hemostatic capabilities of a novel vascular sealing device consisting of a balloon catheter and procoagulant. Vascular sheaths were placed percutaneously in the femoral arteries of dogs. The sealing device was evaluated using the balloon catheter alone in 6 femoral arteries and with the addition of a procoagulant in 21 femoral arteries.

A novel vascular sealing device for closure of percutaneous arterial access sites.

The purpose of this study was to investigate the safety and efficacy of a novel vascular sealing device that incorporates a unique low-profile balloon-positioning catheter and a procoagulant delivered after diagnostic cardiac catheterization and percutaneous transluminal coronary angioplasty (PTCA) procedures. Current management of the vascular access site after percutaneous interventions is associated with patient discomfort and complications. Based on previously reported successful results in canine models, we proceeded with this first human feasibility and safety study.

Novel vascular sealing device for closure of percutaneous vascular access sites.

To investigate the hemostatic capabilities of a novel vascular sealing device consisting of a balloon catheter and procoagulant, vascular sheaths were placed percutaneously in the femoral arteries of dogs. The sealing device was evaluated using the balloon catheter alone in six femoral arteries and with the addition of a procoagulant, in 21 femoral arteries. The balloon catheter alone was successfully deployed in six of six femoral arteries achieving immediate hemostasis.

Regression of severe atherosclerotic plaque in patients with mild elevation of LDL cholesterol.

Background: Intensive risk factor reduction in patients with dyslipidemias and coronary atherosclerosis has been shown to result in alterations in coronary artery morphology and reduced clinical events. However, the impact of such interventions in populations with relatively normal levels of low-density lipoproteins (LDL) is unclear.

Methods: To test the hypothesis that intensive risk factor reduction results in angiographic regression in patients with only mildly elevated levels of LDL, 14 patients with angiographically proven coronary atherosclerosis were entered into the University of California Davis Coronary Artery Disease Regression Program and intensively treated with pharmacologic and nonpharmacologic interventions for 2 years.

Coronary angioplasty of branch vessels associated with an extreme angle take-off.

Stenoses in branch vessels which originate at acute angle to the main vessel represent a technically challenging anatomy for the performance of balloon angioplasty [PTCA]. We report a novel technique utilizing a distally placed perfusion balloon that facilitated guidewire placement and subsequent balloon angioplasty of a branch vessel stenosis.

Intracoronary Doppler flow to monitor the results of selective saphenous vein graft thrombolytic therapy.

Selective intracoronary thrombolytic therapy has recently been advocated as a technique to recanalize occluded coronary bypass grafts. We report a novel approach for monitoring the results of this treatment utilizing a coronary artery doppler flow guidewire. This approach may optimize the duration of thrombolytic treatment in these patients.

Balloon catheter retrieval of dislodged coronary artery stents: a novel technique.

Potential complications of intracoronary stenting include stent dislodgement and embolization. We describe a patient in whom a stent was dislodged from a coronary balloon catheter to the iliac artery. A peripheral angioplasty balloon was used to withdraw the stent into the arterial sheath and thereby remove it from the patient.

Reversible coronary artery kinking caused by cardiopulmonary support.

Cardiopulmonary support is utilized to provide optimal hemodynamic stability in high risk patients undergoing percutaneous transluminal coronary angioplasty. This report describes a patient undergoing supported angioplasty in whom multiple new severe stenoses were noted following coronary dilation and that were completely reversed by discontinuing cardiopulmonary support.

Coronary thrombus: a novel catheter-based approach to treatment.

The presence of coronary thrombus during intracoronary interventions increases the risk of complications during the procedure. We describe a novel approach to infusing thrombolytic agents selectively into a coronary artery utilizing a new low-profile perfusion balloon. This approach may add a useful new treatment for resistant intracoronary thrombi.

Percutaneous transluminal coronary angioplasty of chronic total occlusions. Primary success, restenosis, and long-term clinical follow-up.

Background: Angioplasty of chronically totally occluded vessels has been associated with a success rate well below and restenosis rate well above that for angioplasty of stenosed segments. However, long-term clinical outcome after successful revascularization of a chronically totally occluded vessel has not been reported in detail.

Methods And Results: Accordingly, data for 480 patients undergoing angioplasty for chronic total occlusion at Emory University Hospital, Atlanta, Ga.

Correction of subclavian artery stenosis by percutaneous angioplasty.

Subclavian artery stenosis is an infrequently recognized cause of left-sided chest and arm pain that can mimic the signs and symptoms of angina pectoris. In addition, more proximal subclavian artery stenoses can be associated with cerebrovascular symptoms in the "subclavian steal syndrome." This article reviews the clinical experience in four patients who presented with different manifestations of subclavian artery stenosis and who were all successfully treated by percutaneous angioplasty.

Risk factors, time course and treatment effect for restenosis after successful percutaneous transluminal coronary angioplasty of chronic total occlusion.

Advances in technology and operator experience, and increased use of angiography early after myocardial infarction have led to greater use of percutaneous transluminal coronary angioplasty (PTCA) for chronic, total coronary artery occlusions. To better assess long-term outcome, 257 consecutive patients with successful PTCA of a total occlusion with late angiographic follow-up from 484 patients (53%) with PTCA success were reviewed. The mean +/- standard deviation patient age was 54 +/- 10 years, 79% were men, the duration of total occlusion was 11 +/- 15 weeks and the post-PTCA diameter stenosis was 24 +/- 12%.