Clinical Trial News

Randall Frey

Devices

The ASSESS Study is a phase IV trial investigating the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Because literature shows stent fracture in nitinol stents with a possible clinical relationship, this nonrandomized, open-label, uncontrolled study will analyze the stent fractures of the ABSOLUTE stent, and a possible relationship between stent fracture and restenosis.

This single group assignment, treatment efficacy study has a primary end point of restenosis rate at 6-month follow-up as determined by duplex ultrasound. Secondary outcomes include restenosis rate at 12- and 24-month follow-up, also determined by duplex ultrasound; clinically driven target lesion revascularization at 12- and 24-month follow-up; target lesion primary, primary assisted, and secondary patency rates at 6-, 12-, and 24-month follow-up. The study, sponsored by the Guidant Corporation, began in March 2005 and expects to enroll 120 patients.

Association Between Peripheral Artery Stiffness and Cardiovascular Disease is an observational study using a self-made arterial pulse wave velocity (PWV) measurement device to investigate the correlation of the PWV in the high cardiovascular risk population, then comparing it with normal population. Because PWV is strongly correlated with atherosclerosis, and the PWV of carotid or femoral artery could predict the severity of arterial atherosclerosis, the noninvasive measurement of PWV is expected to serve as a good clinical and screen marker to evaluate the extent of atherosclerosis. This screening, cross-sectional, defined population, retrospective study is sponsored by the National Taiwan University Hospital; it started in May 2005 and expects a total enrollment of 200 patients.

The Boston Scientific ENOVUS Trial is a phase II interventional study to evaluate the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft in the treatment of abdominal aortic aneurysms (AAAs). This prospective, actively controlled, consecutively enrolling, nonrandomized multicenter clinical trial will compare the rate of major morbidity, within 30 days of initial procedures, in a Treatment Group of AAA patients receiving the ENOVUS Endograft against the rate of major morbidity in a Control Group of AAA patients treated with conventional open surgery.

As another primary outcome, the trial will evaluate the efficacy of the Endograft by determining the proportion of patients in the Treatment Group that are free from AAA rupture and conversion to open surgical repair within 1 year of the initial procedure. This study, sponsored by the Boston Scientific Corporation, expects to enroll 307 patients but had not opened to patient recruitment at press time.

Drugs/General

Evaluation of Fibrin Sealant in Vascular Surgical Procedures is a phase III interventional study comparing the effects of a fibrin sealant (FS2) with manual compression on hemostatic efficacy during vascular surgical procedures using polytetrafluorethylene graft material on an end-to-side femoral or upper extremity vascular access arterial anastomosis. This randomized, single-blind, active control, parallel assignment, safety/efficacy study's primary end point is the attainment of hemostasis following randomization. Secondary outcomes include incidence of treatment failures, incidence of potential bleeding-related complications, and adverse events. The study, sponsored by Ethicon Inc. in collaboration with OMRIX biopharmaceuticals Ltd., started in June 2005 and plans to enroll 150 patients.

Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) is a phase III interventional study seeking to optimize physical functioning, increase activity levels, and reduce cardiovascular disease risk in older individuals with peripheral arterial disease (PAD). Sponsored by the National Heart, Lung, and Blood Institute, this randomized treatment trial will test the primary hypothesis that aortoiliac stenting/pharmacotherapy improves maximum walking duration (MWD) better than supervised exercise rehabilitation/exercise maintenance/pharmacotherapy for those with aortoiliac artery obstruction at 6 months.

Other aims are to compare these two treatment groups with a third group, usual care/pharmacotherapy, at 6 months, and to compare all three groups with regard to the following variables: MWD change score at 18 months, changes in free-living daily activity levels, patient-perceived quality of life, and cost-effectiveness. Launched in August 2005, the planned 5-year trial seeks to enroll an estimated 246 patients at nine study sites but had not started patient recruitment at press time.

The use of nesiritide in thoracic aortic aneurysm repair to prevent acute renal failure is a phase III study examining the prophylactic potential of the brain natriuretic peptide when given prior to TAA surgery as a means of preventing acute renal failure requiring dialysis and/or to decrease mortality. The study has an expected enrollment of 124 patients with a planned completion of December 2007, and is being conducted under the sponsorship of Abulate A. Ejaz, M.D., Shands Hospital, the University of Florida, Gainesville.