N/A
N=1,204
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
Peripheral Arterial Occlusive Disease
Bottom Line
View on ClinicalTrials.gov: NCT01855412 ↗Enrolled (actual)
1,204
Serious AEs
29.3%
Results posted
May 2021
Primary outcome: Primary: Procedural Success of Endovascular PAD Treatment(s) — 83.6; 75.8; 68.5 percent of procedures
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PAD endovascular treatments (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedural Success of Endovascular PAD Treatment(s) |
83.6; 75.8; 68.5 | — |
| PRIMARY Lesion Success of Endovascular PAD Treatment(s) |
84.9; 79.1; 75.2 | — |
| PRIMARY Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years |
82.1; 73.2; 59.3; 70.3; 62.0; 47.4 | — |
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).
Eligibility Criteria
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.
- 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 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.
Data sourced from ClinicalTrials.gov (NCT01855412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.