Status:
COMPLETED
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
Lead Sponsor:
Abbott Medical Devices
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Brief Summary
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).
Detailed Description
This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing endovascular treatment of lesions within or extending into the targ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 11 2019
Estimated Enrollment :
1204 Patients enrolled
Trial Details
Trial ID
NCT01855412
Start Date
May 1 2013
End Date
April 11 2019
Last Update
July 18 2023
Active Locations (52)
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1
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
Phoenix Heart Cardiovascular
Glendale, Arizona, United States, 85306
3
St. Luke's Medical Center
Phoenix, Arizona, United States, 85006
4
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211