Status:
TERMINATED
FIRE-PAD: Functional Improvement Through Revascularization of the Extremities for Peripheral Arterial Disease
Lead Sponsor:
The Cleveland Clinic
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
40-85 years
Brief Summary
The specific aims of the project are as follows: To determine whether catheter-based revascularization procedures improve functional capacity and quality of life among patients with intermittent clau...
Detailed Description
Patients with intermittent claudication have decreased functional abilities and impaired quality of life \[QOL\]. In addition, peripheral arterial disease is associated with an increased risk of a lif...
Eligibility Criteria
Inclusion
- • Males and female between 40 and 85 years of age
- subjects referred to The Cleveland Clinic Foundation for a catheter-based revascularization procedure as treatment of intermittent claudication
- Leg symptoms consistent with intermittent claudication for a period of at least 3 months
- Ankle-brachial index (ABI) in the leg to be revascularized must be \< 0.90 or demonstration of post exercise fall in ABI to \< 0.9 for subjects with aortoiliac disease
- Subjects scheduled for both aortoiliac and/or femoropopliteal revascularization procedures will be eligible
- Subjects with bilateral leg symptoms may be enrolled, as long as bilateral revascularization procedures are planned
Exclusion
- • Vascular anatomy inappropriate for a catheter-based procedure on the basis of non-invasive studies
- Critical limb ischemia (rest pain, non-healing ulcer, gangrene)
- Contraindication to contrast arteriography
- Vascular surgery or prior catheter-based vascular intervention within the preceding 6 months
- Patients with suspected or confirmed graft stenoses or occlusions
- Myocardial infarction or hospitalization for unstable angina, coronary artery bypass grafting or percutaneous coronary intervention, within the preceding one month
- Stroke or transient ischemic attack within the preceding one month
- Pregnancy or planned pregnancy during the one year of participation in the trial.
- Any active chronic inflammatory condition,including autoimmune disorder or active malignancy.Subjects unable to walk, amputees, and subjects with a contraindication to treadmill exercise.
- Patients with dementia or other significant cognitive impairment
- Patients who are non-English speaking, (due to the need for subjects to complete standardized questionnaires)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00274157
Start Date
March 1 2007
End Date
March 1 2008
Last Update
June 27 2008
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195