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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.

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