N/A
Completed N=1,204
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
Peripheral Arterial Occlusive Disease
Source: ClinicalTrials.gov NCT01855412 ↗
Enrolled (actual)
1,204
Serious AEs
29.3%
Results posted
May 2021
Primary outcomePrimary: Procedural Success of Endovascular PAD Treatment(s) — 83.6; 75.8; 68.5 percent of procedures
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).
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 | — |
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. Informational only — not medical advice.