Viewing Study NCT00407940



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00407940
Status: WITHDRAWN
Last Update Posted: 2019-06-13
First Post: 2006-12-04

Brief Title: ATHERO Advanced Technology Halting Early Re-Stenosis and Occlusion
Sponsor: University of California San Diego
Organization: University of California San Diego

Study Overview

Official Title: ATHERO Advanced Technology Halting Early Re-Stenosis and Occlusion A Prospective Randomized Trial Comparing Silverhawk Atherectomy to CryoPlasty Therapy for Lower Extremity Claudication
Status: WITHDRAWN
Status Verified Date: 2019-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The rise of minimal access surgery has heralded the approval of a number of endovascular devices with similar indications This is particularly true for the treatment of lower extremity ischemia Comparable devices are selected for patient use somewhat arbitrarily often dependent on industry influence An unmet need is NON-industry sponsored prospective trials COMPARING devices head-to-head so that endovascular surgeons can even contemplate evidence-based device selection At present we seek to compare two new high-technology devices that are indicated to treat lower extremity arterial stenoses associated with claudication
Detailed Description: Peripheral arterial disease affects more than 12 million Americans and its incidence is growing annually The malefemale ratio of patients with claudication is just under 21 The arteries involved by atherosclerosis involve the arteries to the thigh and leg These include the femoral and popliteal arteries Fifty percent of people with femoral-popliteal PVD are symptomatic Symptoms are typically related to exertional fatigue of thigh and calf muscles These symptoms referred to as claudication seldom represent a life or even limb-threatening process They do however result in significantly decreased productivity and an often devastating quality of life

Traditional interventions for lower extremity claudication include technologies invented in the first half of the 20th century including surgical bypass and those invented in the second half of the twentieth century including balloon angioplasty and stenting These interventions have substantial shortcomings It is however relevant to note that endovascular aka endoluminal or endovascular surgery is becoming increasingly popular and gaining wide-spread support from vascular interventionalist societies wordwide

The main shortcomings of angioplasty and stenting is the resultant inflammatory response The mechanical injury to blood vessels is followed by a complex repair response comprising intimal vascular smooth muscle cell VSMC hyperplasia vessel wall scarring and shrinkage of the vascular lumen often resulting in reduced blood flow and subsequent muscle or end organ ischemia Rodent rabbit and large animal models have provided valuable insights into the pathophysiology of these responses

The devices utilized in this protocol are both FDA approved for the procedures described in the protocol The devices include the Silverhawk System FoxHollow Technologies Redwood City CA and the PolarCath Peripheral Dilatation System Boston Scientific Natick Massachusetts Hereafter both products will be referred to as the Devices

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None