FIRE-PAD: Functional Improvement Through Revascularization of the Extremities for Peripheral Arterial Disease

NCT00274157 | Terminated

• 1 other identifier: FIRE-PAD
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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 claudication. To investigate whether improvements in walking ability result in a less sedentary lifestyle and improvement of the cardiovascular risk profile.

Conditions

Peripheral Vascular Disease

Keywords

Peripheral Vascular Disease; Intermittent Claudication; Catheter-based Arterial Revascularization; Peripheral angioplasty; Peripheral stenting; Functional capacity; Quality of life

Interventions

Behavior BEHAVIORAL

diet control, smoking cessation, exercize BEHAVIORAL

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heather L Gornik, M.D. M.H.S.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 10, 2006
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 27, 2008

Record last verified: 2008-06

Locations

US (1)