Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

Completed

Conditions studied: Peripheral Arterial Occlusive Disease

In brief

The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).

Key facts

Study ID

NCT01855412

Run by

Abbott Medical Devices

People needed

1204

Starts

2013-05-01

Expected to finish

2019-04-11

Last updated by the study team

2023-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject's age ≥ 18 years.
• Subject presents with a Rutherford classification of 2 to 6.
• Subject presents with clinical evidence of PAD requiring endovascular intervention on one or both limbs that includes a target lesion in a native vessel located within or extending into 10 cm above the medial epicondyle to the digital arteries.
• If subject presents with bilateral disease, the first limb treated with a lesion in the target area will be considered the target limb.
• For subjects with one or more wounds on the target limb, the target lesion(s) should be considered the lesion(s) in the vessel(s) that provide(s) blood flow to the wound(s).
• Subject has at least one lesion in a native vessel located within or extending into the target area that is crossed and treated with an endovascular device.

You may not qualify if…

• Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).
• Subject is unable to understand or comply with the study protocol requirements.
• Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this study.
• Subject requires a conversion from endovascular intervention to a surgical bypass graft for any lesion(s) in the target area, as determined by the Investigator.
• Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.
• Subject is pregnant or planning to become pregnant within the study period.
• Subject has an anticipated life span of less than one (1) year.

Where it is running

• Phoenix Heart Cardiovascular — Glendale, Arizona, United States
• St. Luke's Medical Center — Phoenix, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Cedars-Sinai Heart Institute — Los Angeles, California, United States
• Denver Heart — Denver, Colorado, United States
• VA Eastern Colorado Healthcare System — Denver, Colorado, United States
• Colorado Heart and Vascular, PC — Lakewood, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale-New Haven Hospital — New Haven, Connecticut, United States
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• The Heart Institute of Largo — Largo, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Mount Sinai Medical Center Heart Institute — Miami Beach, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Coastal Vascular and Intervention — Pensacola, Florida, United States
• Pepin Heart Institute — Tampa, Florida, United States
• Memorial Hospital Carbondale — Carbondale, Illinois, United States
• Chicago Vascular Clinic — Schaumburg, Illinois, United States
• St. John's Hospital Springfield — Springfield, Illinois, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• St. Joseph Hospital — Lexington, Kentucky, United States
• Shady Grove Adventist Hospital — Rockville, Maryland, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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