Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132743
Status:
UNKNOWN
Last Update Posted:
2013-04-25
First Post:
2005-08-19
Brief Title:
Claudication Exercise Versus Endoluminal Revascularization CLEVER
Sponsor:
Joselyn Cerezo MD
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Claudication Exercise Versus Endoluminal Revascularization CLEVER
Status:
UNKNOWN
Status Verified Date:
2013-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
CLEVER
Brief Summary:
The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency
Detailed Description:
BACKGROUND
Peripheral arterial disease PAD is a major source of morbidity and mortality particularly in older individuals Despite its high prevalence clinicians often fail to diagnose PAD particularly in patients who do not have classic claudication symptoms Even in those individuals with documented PAD cardiac risk factors are not often aggressively treated and only a minority of patients receive pharmacologic therapy with cilostazol Although there is a growing body of literature demonstrating the value of exercise rehabilitation in individuals with peripheral vascular disease and claudication exercise rehabilitation is not often prescribed as supervised exercise rehabilitation for claudication is not reimbursed by Medicare and is rarely covered by private insurance Therefore few individuals with PAD and intermittent claudication have access to supervised exercise rehabilitation
The use of surgical intervention and stent placement to improve blood flow in patients who do not have ischemic pain at rest or limb-threatening ischemia Fontaine class III or IV remains controversial There is data suggesting that patients with intermittent claudication who have had revascularization with stents have improved exercise capacity and walking times However the patients in the various studies often differ substantially in their clinical characteristics and a variety of techniques were employed including balloon angioplasty and stents which makes it difficult to come to a definitive conclusion about the relative efficacy of stenting to improve functional performance Additionally to our knowledge the combination of stent revascularization with supervised exercise rehabilitation has not been studied
DESIGN NARRATIVE
The broad objective of the study is to optimize physical functioning increase activity levels and reduce cardiovascular disease risk in older individuals with PAD The specific aim of the trial is to test the primary hypothesis that aortoiliac stentingpharmacotherapy improves maximum walking duration MWD better than supervised exercise rehabilitationexercise maintenancepharmacotherapy for those with aortoiliac artery obstruction at 6 months Other aims are to compare these two treatment groups with two other treatment groups optimal medical carepharmacotherapy and combined stent plus supervised exercise rehabilitation at 6 months and to compare all 4 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 QoL and cost-effectiveness The study also will perform exploratory analyses of demographic and biochemical risk factors for atherosclerosis including body mass index BMI blood pressure lipid profile hemoglobin Alc HgbAlc fibrinogen and C-reactive protein An estimated 252 patients at up to 30 study sites with aortoiliac insufficiency and intermittent claudication will be randomly divided into four groups optimal medical carepharmacotherapy supervised exercise rehabilitationmaintenancepharmacotherapy stentpharmacotherapy and stentsupervised exercise rehabilitationpharmacotherapy Recruitment will be performed over 28 months and patients will be followed for 18 months the total study duration will be 5 years
Peripheral arterial disease PAD is a major source of morbidity and mortality particularly in older individuals Despite its high prevalence clinicians often fail to diagnose PAD particularly in patients who do not have classic claudication symptoms Even in those individuals with documented PAD cardiac risk factors are not often aggressively treated and only a minority of patients receive pharmacologic therapy with cilostazol Although there is a growing body of literature demonstrating the value of exercise rehabilitation in individuals with peripheral vascular disease and claudication exercise rehabilitation is not often prescribed as supervised exercise rehabilitation for claudication is not reimbursed by Medicare and is rarely covered by private insurance Therefore few individuals with PAD and intermittent claudication have access to supervised exercise rehabilitation
The use of surgical intervention and stent placement to improve blood flow in patients who do not have ischemic pain at rest or limb-threatening ischemia Fontaine class III or IV remains controversial There is data suggesting that patients with intermittent claudication who have had revascularization with stents have improved exercise capacity and walking times However the patients in the various studies often differ substantially in their clinical characteristics and a variety of techniques were employed including balloon angioplasty and stents which makes it difficult to come to a definitive conclusion about the relative efficacy of stenting to improve functional performance Additionally to our knowledge the combination of stent revascularization with supervised exercise rehabilitation has not been studied
DESIGN NARRATIVE
The broad objective of the study is to optimize physical functioning increase activity levels and reduce cardiovascular disease risk in older individuals with PAD The specific aim of the trial is to test the primary hypothesis that aortoiliac stentingpharmacotherapy improves maximum walking duration MWD better than supervised exercise rehabilitationexercise maintenancepharmacotherapy for those with aortoiliac artery obstruction at 6 months Other aims are to compare these two treatment groups with two other treatment groups optimal medical carepharmacotherapy and combined stent plus supervised exercise rehabilitation at 6 months and to compare all 4 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 QoL and cost-effectiveness The study also will perform exploratory analyses of demographic and biochemical risk factors for atherosclerosis including body mass index BMI blood pressure lipid profile hemoglobin Alc HgbAlc fibrinogen and C-reactive protein An estimated 252 patients at up to 30 study sites with aortoiliac insufficiency and intermittent claudication will be randomly divided into four groups optimal medical carepharmacotherapy supervised exercise rehabilitationmaintenancepharmacotherapy stentpharmacotherapy and stentsupervised exercise rehabilitationpharmacotherapy Recruitment will be performed over 28 months and patients will be followed for 18 months the total study duration will be 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL077221 | NIH | None | httpsreporternihgovquickSearchU01HL077221 |
| U01HL081656 | NIH | None | None |