CompletedNot Applicable

Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

United States1,204 participantsStarted 2013-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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 criteria

✕. 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.

What they're measuring

Procedural Success of Endovascular PAD Treatment(s)

Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Lesion Success of Endovascular PAD Treatment(s)

Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years

Timeframe: One (1) year and three (3) years post-procedure

Trial details

NCT IDNCT01855412

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-04-11

Results submitted2021-03-12

View on ClinicalTrials.gov More Peripheral Arterial Occlusive Disease trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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 criteria

✕. 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.

What they're measuring

Procedural Success of Endovascular PAD Treatment(s)

Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Lesion Success of Endovascular PAD Treatment(s)

Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years

Timeframe: One (1) year and three (3) years post-procedure